| 2026-08-18 |
Class II
|
Ongoing |
Z-3264-2026 |
PRO+ 40" MRS SURFACE, mattress with Advanced Microclimate Technology (AMT) uses a non-powered system of intake and outpu… |
— |
There is an error in the product description on the Unique Device Identification (UDI) label. These discrepancies in labeling do not align with the approved pro… |
| 2026-08-18 |
Class II
|
Ongoing |
Z-3263-2026 |
PRO+ 36" MRS SURFACE, mattress with Advanced Microclimate Technology (AMT) uses a non-powered system of intake and outpu… |
— |
There is an error in the product description on the Unique Device Identification (UDI) label. These discrepancies in labeling do not align with the approved pro… |
| 2026-08-18 |
Class II
|
Ongoing |
Z-3262-2026 |
PRO+ MRS SURFACE FOR VERSACARE, mattress with Advanced Microclimate Technology (AMT) uses a non-powered system of intake… |
— |
There is an error in the product description on the Unique Device Identification (UDI) label. These discrepancies in labeling do not align with the approved pro… |
| 2026-08-11 |
Class II
|
Ongoing |
Z-3066-2026 |
Baxter Novum IQ Syringe Pump, Loaner, Model Number 40800BAXUSL |
— |
A software issue that may occur during a Volume/Time (VOT) multi-syringe infusion when a syringe reaches empty and is replaced while a Volume To Be Infused (VTB… |
| 2026-08-11 |
Class II
|
Ongoing |
Z-3065-2026 |
Baxter Novum IQ Syringe Pump, Model Number 40800BAXUS |
— |
A software issue that may occur during a Volume/Time (VOT) multi-syringe infusion when a syringe reaches empty and is replaced while a Volume To Be Infused (VTB… |
| 2026-02-18 |
Class I
|
Ongoing |
Z-1637-2026 |
Blue Ventilator Adapter Module, single-patient use circuit, Product Code M07937. Accessory to Baxter Volara Respiratory… |
— |
Urgent Medical Device Correction for the Volara system single-patient use circuit due to the potential that patients or caregivers may be unaware of a possible … |
| 2026-02-18 |
Class II
|
Ongoing |
Z-1573-2026 |
Brand Name: Welch Allyn, Inc. Product Name: Welch Allyn Spot Vision Screener VS100 Model/Catalog Number: VS100 Softwa… |
— |
Display screen may unintentionally flicker due to a software issue. Exposure to flickering lights may induce photosensitive seizure activity in susceptible indi… |
| 2026-01-13 |
Class II
|
Ongoing |
Z-1368-2026 |
Brand Name: Spectrum IQ Product Name: Infusion Pump Model/Catalog Number: 3570009 Software Version: N/A Product Desc… |
— |
Pumps were released without full testing being performed, including occlusion alarm testing. |
| 2025-11-28 |
Class II
|
Ongoing |
Z-1121-2026 |
SIGMA Spectrum Infusion Pump, Model/Catalog Number: 35700BAX2 |
— |
Certain pumps have potentially been released from service with defective grease applied to the cam and motor gears. Due to its low viscosity, the defective grea… |
| 2025-10-28 |
Class II
|
Ongoing |
Z-0847-2026 |
Welch Allyn INF BAG, Thigh 1-Tube, Model/Catalog Number: REF 5089-18; Product replacement bladder for the Welch Allyn T… |
— |
Replacement bladder kit for the Welch Allyn two-piece reusable blood pressure cuff may contain a Large Adult size bladder rather than a Thigh size bladder in th… |
| 2025-09-17 |
Class II
|
Ongoing |
Z-0233-2026 |
Oral Probe (Product code 02893-000), accessory used with Welch Allyn SureTemp Plus 690 (Product codes 01690-200 and 0169… |
— |
Affected oral/axillary probes were inadvertently programmed with the rectal probe configuration. Affected probes will potentially display a lower temperature th… |
| 2025-08-29 |
Class II
|
Ongoing |
Z-0204-2026 |
CLEARLINK SYSTEM NON-DEHP CONTINU-FLO SOLN SET, 96" (2,4 m), Product Code: 2H8519 |
— |
IV sets may leak. |
| 2025-08-29 |
Class II
|
Ongoing |
Z-0203-2026 |
CLEARLINK System Paclitaxel Set, Non-Vented with Polyethylene Lined Tubing and CLEARLINK Luer Activated Valve, 0.2 Micro… |
— |
IV sets may leak. |
| 2025-08-29 |
Class II
|
Ongoing |
Z-0202-2026 |
CLEARLINK SYSTEM CONTINU-FLO Solution Set, Non-Vented, three CLEARLINK Luer Activated Valves, Backcheck Valve, 10 drops/… |
— |
IV sets may leak. |
| 2025-08-29 |
Class II
|
Ongoing |
Z-0201-2026 |
CLEARLINK SYSTEM CONTINU-FLO Solution Set, Non-Vented, two CLEARLINK Luer Activated Valves. 10 drops/mL, 96-inch (2.4 me… |
— |
IV sets may leak. |
| 2025-08-29 |
Class II
|
Ongoing |
Z-0200-2026 |
CLEARLINK System Non_DEHP Extenstion Set, Straight-Type Extension Set, Standard Bore, 1.2 Micron Filter, CLEARLINK Luer… |
— |
IV sets may leak. |
| 2025-08-29 |
Class II
|
Ongoing |
Z-0199-2026 |
CLEARLINK SYSTEM EXTENSION SET, Straight-Type Extension Set, Standard Bore, CLEARLINK Luer Activated Valve, Retractable… |
— |
IV sets may leak. |
| 2025-08-29 |
Class II
|
Ongoing |
Z-0198-2026 |
CLEARLINK SYSTEM EXTENSION SET, Straight-Type Extension Set, Standard Bore, CLEARLINK Luer Activated Valve, Retractable … |
— |
IV sets may leak. |
| 2025-08-29 |
Class II
|
Ongoing |
Z-0197-2026 |
CLEARLINK SYSTEM EXTENSION SET, Straight-Type Extension Set, Standard Bore, CLEARLINK Luer Activated Valve, Retractable… |
— |
IV sets may leak. |
| 2025-08-29 |
Class II
|
Ongoing |
Z-0196-2026 |
CLEARLINK SYSTEM CONTINU-FLO Solution Set, Non-Vented, 0.2 Micron Filter, three CLEARLINK Luer Activated Valves, Backche… |
— |
IV sets may leak. |
| 2025-08-29 |
Class II
|
Ongoing |
Z-0195-2026 |
CLEARLINK SYSTEM CONTINU-FLO Solution Set, Non-Vented, 0.2 Micron Filter, two CLEARLINK Luer Activated Valves, Backcheck… |
— |
IV sets may leak. |
| 2025-08-29 |
Class II
|
Ongoing |
Z-0194-2026 |
CLEARLINK SYSTEM CONTINU-FLO Solution Set, Non-Vented, three CLEARLINK Luer Activated Valves, Backcheck Valve, Retractab… |
— |
IV sets may leak. |
| 2025-08-29 |
Class II
|
Ongoing |
Z-0193-2026 |
CLEARLINK SYSTEM CONTINU-FLO Solution Set, Non-Vented, three CLEARLINK Luer Activated Valves, Backcheck Valve, Retractab… |
— |
IV sets may leak. |
| 2025-08-29 |
Class II
|
Ongoing |
Z-0192-2026 |
CLEARLINK SYSTEM CONTINU-FLO Solution Set, Non-Vented, two CLEARLINK Luer Activated Valves, Backcheck Valve, 10 drops/mL… |
— |
IV sets may leak. |
| 2025-08-29 |
Class II
|
Ongoing |
Z-0191-2026 |
CLEARLINK SYSTEM Solution Set, Non-Vented, two CLEARLINK Luer Activated Valves, 10 drops/mL, 100-inch (2.5 meters), Prod… |
— |
IV sets may leak. |
| 2025-08-29 |
Class II
|
Ongoing |
Z-0190-2026 |
CLEARLINK System Solution Set, DUO-VENT, CLEARLINK Luer Activated Valve, 10 drops/mL, 92-inch (2.3 meters), Product code… |
— |
IV sets may leak. |
| 2025-08-29 |
Class II
|
Ongoing |
Z-0189-2026 |
CONTINU-FLO Solution Set, Non-Vented, two CLEARLINK Luer Activated Valves, Backcheck Valve, Plus 4-Way Stopcock Extensio… |
— |
IV sets may leak. |
| 2025-08-08 |
Class II
|
Ongoing |
Z-2594-2025 |
Baster Continu-Flo Solution Set, Non-Vented, 2 Clearlink Luer Activated Valves, Backcheck Valve. 10 drops/mL. 112" (2.8 … |
— |
Baxter Healthcare Corporation is issuing an Urgent Medical Device Recall for one lot of Continu-Flo solution sets listed below due to customer reports of tubing… |
| 2025-08-04 |
Class I
|
Ongoing |
Z-2334-2025 |
Novum IQ Syringe Pump, Product Code 40700BAX, infusion pump |
— |
Baxter Healthcare Corporation is issuing an Urgent Medical Device Correction for the Novum IQ Large Volume Pump (LVP) and Novum IQ Syringe Pump (SP) due to soft… |
| 2025-08-04 |
Class I
|
Ongoing |
Z-2333-2025 |
Novum IQ Syringe Pump, Product Code 40800BAXUS, infusion pump |
— |
Baxter Healthcare Corporation is issuing an Urgent Medical Device Correction for the Novum IQ Large Volume Pump (LVP) and Novum IQ Syringe Pump (SP) due to soft… |
| 2025-08-04 |
Class I
|
Ongoing |
Z-2332-2025 |
Novum IQ LVP (Large Volume Pump), Product Code 40700BAXUS, infusion pump |
— |
Baxter Healthcare Corporation is issuing an Urgent Medical Device Correction for the Novum IQ Large Volume Pump (LVP) and Novum IQ Syringe Pump (SP) due to soft… |
| 2025-07-14 |
Class II
|
Ongoing |
Z-2415-2025 |
Spectrum IQ Infusion Pump, Product Code 3570009 |
— |
Baxter has identified that certain pumps have potentially been released with the grease applied to the cam and motor gears that will break down quickly. The bre… |
| 2025-07-14 |
Class I
|
Ongoing |
Z-2173-2025 |
Baxter Novum IQ Large Volume Pump, Product Code REF 40700BAXUS |
— |
Baxter is issuing an Urgent Medical Device Correction for the Novum IQ large volume pump (LVP) due to the potential for underinfusion when transitioning from a … |
| 2025-06-20 |
Class I
|
Ongoing |
Z-2096-2025 |
Baxter SIGMA Spectrum Infusion Pump V8, Model Number 35700BAX2 |
— |
Certain Spectrum infusion pumps may have an incorrect version of software. |
| 2025-06-20 |
Class I
|
Ongoing |
Z-2095-2025 |
Baxter SIGMA Spectrum Infusion Pump V6, Model Number 35700BAX |
— |
Certain Spectrum infusion pumps may have an incorrect version of software. |
| 2025-05-30 |
Class I
|
Ongoing |
Z-2032-2025 |
Hillrom LikoScale component, Product Code 3156232, used with the following adapter kits for patient lifts: 1) LikoSc… |
— |
The Q-link 13 could allow for an improper attachment (false latching) of the Quick-Release Hook used on Sling Bars and other accessories. This could result in a… |
| 2025-05-30 |
Class I
|
Ongoing |
Z-2031-2025 |
Hillrom Q-Link 13 component, Product Code 3156509, used with the following Mobile Patient Lifts: 1) Uno 102 EE Mobile… |
— |
The Q-link 13 could allow for an improper attachment (false latching) of the Quick-Release Hook used on Sling Bars and other accessories. This could result in a… |
| 2025-05-12 |
Class II
|
Ongoing |
Z-1964-2025 |
Baxter Novum IQ Syringe Pump, product code 40800BAXUS, |
— |
Baxter has identified a design issue which may cause the pump to detect the presence of a syringe flange when no syringe is loaded. When this issue occurs, the … |
| 2025-05-09 |
Class II
|
Ongoing |
Z-1962-2025 |
2.5 V replacement rechargeable batteries for Hillrom WELCH ALLYN PocketScope handles, Product Code 72600 |
— |
The replacement rechargeable batteries inserted into the Welch Allyn PocketScope handles have the potential to cause a short circuit in the handle, which can le… |
| 2025-05-06 |
Class II
|
Ongoing |
Z-1816-2025 |
Affinity 4 Birthing Bed, Product Codes P3700E100429, P3700E100432, P3700E100433, P3700E100434, P3700E100435, P3700E10043… |
— |
There is a potential for improper crimps on the signal wires of the actuators which could result in a loss of ability to lower the bed or the foot section of th… |
| 2025-04-24 |
Class I
|
Ongoing |
Z-1767-2025 |
Baxter Novum IQ LVP INFUSION SYSTEM, REF 40700BAXUS |
— |
There is a potential for the Novum IQ LVP due to the potential for underinfusion following use of the "standby mode" feature or if the device is powered off wit… |
| 2025-04-07 |
Class I
|
Ongoing |
Z-1726-2025 |
Welch Allyn Life2000 Compressor, Product Codes: 1) BT-80-0004; 2) BT-80-0004A; 3) BT-80-0008; 4) BT-80-0008A; … |
— |
A cybersecurity vulnerability was discovered through internal testing. |
| 2025-04-07 |
Class I
|
Ongoing |
Z-1725-2025 |
Welch Allyn Life2000 Ventilation system, Product Codes: 1) BT-20-0002; 2) BT-20-0002A; 3) BT-20-0002AP; 4) BT20… |
— |
A cybersecurity vulnerability was discovered through internal testing. |
| 2025-03-24 |
Class II
|
Ongoing |
Z-1560-2025 |
Welch Allyn CP150 Electrocardiograph: |
— |
There were customer reports of devices which experienced battery-related fires. The investigation found that the devices in question were utilizing third-party,… |
| 2025-03-24 |
Class II
|
Ongoing |
Z-1559-2025 |
Welch Allyn CONNEX Accessory Power Management Stand: |
— |
There were customer reports of devices which experienced battery-related fires. The investigation found that the devices in question were utilizing third-party,… |
| 2025-03-24 |
Class II
|
Ongoing |
Z-1558-2025 |
Welch Allyn Connex Vital Signs Monitor (CVSM): |
— |
There were customer reports of devices which experienced battery-related fires. The investigation found that the devices in question were utilizing third-party,… |
| 2025-03-21 |
Class II
|
Ongoing |
Z-1568-2025 |
Welch Allyn 2-Piece Reusable Blood Pressure Cuff Kits labeled as: 1. WELCH ALLYN 2-Piece Reusable Blood Pressure Cuff… |
— |
Undeclared natural rubber band within the packaging of certain configurations of reusable blood pressure cuffs. |
| 2025-03-21 |
Class II
|
Ongoing |
Z-1567-2025 |
Welch Allyn DuraShock Aneroid Gauge Sets with a Reusable Blood Pressure Cuff labeled as: 1) WELCH ALLYN DURASHOCK Ane… |
— |
Undeclared natural rubber band within the packaging of certain configurations of reusable blood pressure cuffs. |
| 2025-03-21 |
Class II
|
Ongoing |
Z-1566-2025 |
Welch Allyn Green Series 777 Wall System, Product Code/Part Numbers: 1) 77791-2MP2X; 2) 77791-2MP2XL; 3) 77791-2M… |
— |
Undeclared natural rubber band within the packaging of certain configurations of reusable blood pressure cuffs. |
| 2025-03-21 |
Class II
|
Ongoing |
Z-1565-2025 |
Welch Allyn Spot Vital Signs 4400 Device, Product Code/Part Numbers: 1) 44WT-2; 2) 44WT-3; 3) 44WT-4; 4) 44WT-6… |
— |
Undeclared natural rubber band within the packaging of certain configurations of reusable blood pressure cuffs. |
| 2025-03-21 |
Class II
|
Ongoing |
Z-1564-2025 |
Welch Allyn Connex Vital Signs Monitor, Product Code/Part Numbers: 1) ) Product Code/Part # 67MXTP-B-ECG3A; 2) ) Pr… |
— |
Undeclared natural rubber band within the packaging of certain configurations of reusable blood pressure cuffs. |
| 2025-03-21 |
Class II
|
Ongoing |
Z-1563-2025 |
Welch Allyn Welch Allyn Connex Spot Monitor, Product Code/ Part Numbers: 1) 73WT-B; 2) 74CE-B; 3) 74CT-B; 4) 74… |
— |
Undeclared natural rubber band within the packaging of certain configurations of reusable blood pressure cuffs. |
| 2025-03-21 |
Class II
|
Ongoing |
Z-1562-2025 |
Welch Allyn Connex Integrated Wall System, Product Code/Part Numbers: 1) 84MTVE2-4; 2) 84MTVE2-6; 3) 84MTVE2-B; … |
— |
Undeclared natural rubber band within the packaging of certain configurations of reusable blood pressure cuffs. |
| 2025-03-03 |
Class II
|
Ongoing |
Z-1423-2025 |
Baxter NovumIQ Syringe INFUSION SYSTEM , REF 40800BAXUS |
— |
Baxter Healthcare Corporation is issuing an Urgent Medical Device Recall for the Novum IQ syringe pumps listed below due to an incorrectly installed gasket. A g… |
| 2025-02-25 |
Class II
|
Ongoing |
Z-1468-2025 |
Progressa Bed Surfaces, intended to be used to treat or prevent pulmonary or other complications associated with immobil… |
— |
The air bladders inside the mattress may move out of position when the head of the bed is elevated, causing a dip in the mattress. |
| 2025-02-25 |
Class II
|
Ongoing |
Z-1422-2025 |
Baxter TruSystem 7500, Product Code 4091000 |
— |
There is a software issue which causes the upper back section to not be operable/adjustable when the "emergency mode" function is enabled. |
| 2025-02-25 |
Class II
|
Ongoing |
Z-1421-2025 |
Baxter TruSystem 7500 Hybrid MR IMRIS, Product Code 2067886 |
— |
There is a software issue which causes the upper back section to not be operable/adjustable when the "emergency mode" function is enabled. |
| 2025-02-25 |
Class II
|
Ongoing |
Z-1420-2025 |
Baxter TruSystem 7500 Hybrid Plus (SC), Product Code 1854088 |
— |
There is a software issue which causes the upper back section to not be operable/adjustable when the "emergency mode" function is enabled. |
| 2025-02-25 |
Class II
|
Ongoing |
Z-1419-2025 |
Baxter TruSystem 7500 Hybrid Plus (FC), Product Code 1854087 |
— |
There is a software issue which causes the upper back section to not be operable/adjustable when the "emergency mode" function is enabled. |
| 2025-02-25 |
Class II
|
Ongoing |
Z-1418-2025 |
Baxter TruSystem 7500 Hybrid (SC), Product Code 1854086 |
— |
There is a software issue which causes the upper back section to not be operable/adjustable when the "emergency mode" function is enabled. |
| 2025-02-25 |
Class II
|
Ongoing |
Z-1417-2025 |
Baxter TruSystem 7500 Hybrid (FC), Product Code 1854085 |
— |
There is a software issue which causes the upper back section to not be operable/adjustable when the "emergency mode" function is enabled. |
| 2025-02-25 |
Class II
|
Ongoing |
Z-1416-2025 |
Baxter TruSystem 7500 Hybrid (MC), Product Code 1773204 |
— |
There is a software issue which causes the upper back section to not be operable/adjustable when the "emergency mode" function is enabled. |
| 2025-02-25 |
Class II
|
Ongoing |
Z-1415-2025 |
Baxter Floor mounting column TS 7500 U, Product Code 1730732 |
— |
There is a software issue which causes the upper back section to not be operable/adjustable when the "emergency mode" function is enabled. |
| 2025-02-25 |
Class II
|
Ongoing |
Z-1414-2025 |
Baxter Stationary column TruSystem 7500 U, Product Code 1730731 |
— |
There is a software issue which causes the upper back section to not be operable/adjustable when the "emergency mode" function is enabled. |
| 2025-02-25 |
Class II
|
Ongoing |
Z-1413-2025 |
Baxter Mobile column TruSystem 7500 U, Product Code 1730720 |
— |
There is a software issue which causes the upper back section to not be operable/adjustable when the "emergency mode" function is enabled. |
| 2025-02-25 |
Class II
|
Ongoing |
Z-1412-2025 |
Baxter Mobile column TruSystem 7500, Product Code 1717023 |
— |
There is a software issue which causes the upper back section to not be operable/adjustable when the "emergency mode" function is enabled. |
| 2025-02-25 |
Class II
|
Ongoing |
Z-1411-2025 |
Baxter Floor mounting column TruSystem 7500, Product Code 1717021 |
— |
There is a software issue which causes the upper back section to not be operable/adjustable when the "emergency mode" function is enabled. |
| 2025-02-25 |
Class II
|
Ongoing |
Z-1410-2025 |
Baxter Stationary column TruSystem 7500, Product Code 1717020 |
— |
There is a software issue which causes the upper back section to not be operable/adjustable when the "emergency mode" function is enabled. |
| 2025-02-25 |
Class II
|
Ongoing |
Z-1409-2025 |
Baxter Operating table column TS7500 MOBIUS, Product Code 1704695 |
— |
There is a software issue which causes the upper back section to not be operable/adjustable when the "emergency mode" function is enabled. |
| 2025-02-05 |
Class I
|
Ongoing |
Z-1254-2025 |
Baxter Spectrum IQ Infusion System with Dose IQ Safety Software, Product Code 3570009 |
— |
There is the potential for missing motor mounting screws, which may have occurred during the servicing process. |
| 2025-02-05 |
Class I
|
Ongoing |
Z-1253-2025 |
Baxter Sigma Spectrum Infusion System (V6 Platform), Product Code 35700BAX |
— |
There is the potential for missing motor mounting screws, which may have occurred during the servicing process. |
| 2024-12-20 |
Class II
|
Ongoing |
Z-1011-2025 |
Baxter Continu-Flo Solution Set with Duo-Vent Spike, REF UC8519 |
— |
Specific lots of Solution Sets with Duo-Vent Spike have the potential for inverted side clamps causing the tubing to be unusable. |
| 2024-12-20 |
Class II
|
Ongoing |
Z-1010-2025 |
Baxter Clearlink System Solution Set with Duo-Vent Spike, REF 2R8538 |
— |
Specific lots of Solution Sets with Duo-Vent Spike have the potential for inverted side clamps causing the tubing to be unusable. |
| 2024-12-20 |
Class II
|
Ongoing |
Z-1009-2025 |
Baxter Solution Set with Duo-Vent Spike, REF 2R8404 |
— |
Specific lots of Solution Sets with Duo-Vent Spike have the potential for inverted side clamps causing the tubing to be unusable. |
| 2024-12-20 |
Class I
|
Ongoing |
Z-0887-2025 |
Breathe Technologies, Inc., Life2000 Ventilation System, REF BT-20-0002AP |
— |
There is an issue with the ventilator battery charger that could lead to an audible and visual alarm. If the alarm is engaged, the ventilator becomes inoperable… |
| 2024-12-20 |
Class I
|
Ongoing |
Z-0886-2025 |
Welch Allyn, Inc., Life2000 Ventilation System, REF BT-20-0002AP |
— |
There is an issue with the ventilator battery charger that could lead to an audible and visual alarm. If the alarm is engaged, the ventilator becomes inoperable… |
| 2024-12-20 |
Class I
|
Ongoing |
Z-0885-2025 |
Welch Allyn, Inc., Life2000 Ventilation System, REF BT-20-0002A |
— |
There is an issue with the ventilator battery charger that could lead to an audible and visual alarm. If the alarm is engaged, the ventilator becomes inoperable… |
| 2024-12-20 |
Class I
|
Ongoing |
Z-0884-2025 |
Welch Allyn, Inc., Life 2000 Ventilation System, REF BT-20-0002 |
— |
There is an issue with the ventilator battery charger that could lead to an audible and visual alarm. If the alarm is engaged, the ventilator becomes inoperable… |
| 2024-11-19 |
Class II
|
Ongoing |
Z-0776-2025 |
Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 8), Product Code 35700BAX2 |
— |
Devices were identified as released after repair without full testing being performed, which includes flow testing. |
| 2024-11-19 |
Class II
|
Ongoing |
Z-0775-2025 |
Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 6), Product Code 35700BAX |
— |
Devices were identified as released after repair without full testing being performed, which includes flow testing. |
| 2024-10-23 |
Class II
|
Ongoing |
Z-0569-2025 |
Baxter MiniCap Extended Life PD Transfer Set (short) with Titanium Spike, Part Number T5C4326K; use in Peritoneal Dialy… |
— |
There has been an increase in the number of complaints related to the separation of the female connector from the main body of the transfer set. |
| 2024-10-23 |
Class II
|
Ongoing |
Z-0568-2025 |
Baxter MiniCap Extended Life PD Transfer Set (long) with Titanium Spike, Part Number T5C4325K; use in Peritoneal Dialys… |
— |
There has been an increase in the number of complaints related to the separation of the female connector from the main body of the transfer set. |
| 2024-10-23 |
Class II
|
Ongoing |
Z-0567-2025 |
Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, Part Number T5C4482; use in Peritoneal Dialysis |
— |
There has been an increase in the number of complaints related to the separation of the female connector from the main body of the transfer set. |
| 2024-10-23 |
Class II
|
Ongoing |
Z-0566-2025 |
Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, Part Number R5C4484; use in Peritoneal Dialysis |
— |
There has been an increase in the number of complaints related to the separation of the female connector from the main body of the transfer set. |
| 2024-10-23 |
Class II
|
Ongoing |
Z-0565-2025 |
Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, Part Number R5C4483; use in Peritoneal Dialysis |
— |
There has been an increase in the number of complaints related to the separation of the female connector from the main body of the transfer set. |
| 2024-10-23 |
Class II
|
Ongoing |
Z-0564-2025 |
Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, Part Number R5C4482E; use in Peritoneal Dialysis |
— |
There has been an increase in the number of complaints related to the separation of the female connector from the main body of the transfer set. |
| 2024-10-23 |
Class II
|
Ongoing |
Z-0563-2025 |
Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, Part Number R5C4482; use in Peritoneal Dialysis |
— |
There has been an increase in the number of complaints related to the separation of the female connector from the main body of the transfer set. |
| 2024-10-23 |
Class II
|
Ongoing |
Z-0562-2025 |
Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, Part Number 5C4483; use in Peritoneal Dialysis |
— |
There has been an increase in the number of complaints related to the separation of the female connector from the main body of the transfer set. |
| 2024-10-23 |
Class II
|
Ongoing |
Z-0561-2025 |
Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, Part Number 5C4482S; use in Peritoneal Dialysis |
— |
There has been an increase in the number of complaints related to the separation of the female connector from the main body of the transfer set. |
| 2024-10-23 |
Class II
|
Ongoing |
Z-0560-2025 |
Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, Part Number 5C4482EJ; use in Peritoneal Dialysis |
— |
There has been an increase in the number of complaints related to the separation of the female connector from the main body of the transfer set. |
| 2024-10-23 |
Class II
|
Ongoing |
Z-0559-2025 |
Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, Part Number 5C4482; use in Peritoneal Dialysis |
— |
There has been an increase in the number of complaints related to the separation of the female connector from the main body of the transfer set. |
| 2024-10-21 |
Class I
|
Ongoing |
Z-0382-2025 |
Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp EX Short, Part Number T5C4484; use in Peritoneal Dialysis |
— |
Baxter is aware of several recalls by other manufacturers related to the potential risk of exposure to non-dioxin-like (NDL) polychlorinated biphenyl acids (PC… |
| 2024-10-21 |
Class I
|
Ongoing |
Z-0381-2025 |
Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, Part Number T5C4482; use in Peritoneal Dialysis |
— |
Baxter is aware of several recalls by other manufacturers related to the potential risk of exposure to non-dioxin-like (NDL) polychlorinated biphenyl acids (PC… |
| 2024-10-21 |
Class I
|
Ongoing |
Z-0380-2025 |
Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, Part Number R5C4484; use in Peritoneal Dialysis |
— |
Baxter is aware of several recalls by other manufacturers related to the potential risk of exposure to non-dioxin-like (NDL) polychlorinated biphenyl acids (PC… |
| 2024-10-21 |
Class I
|
Ongoing |
Z-0379-2025 |
Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, Part Number R5C4483; use in Peritoneal Dialysis |
— |
Baxter is aware of several recalls by other manufacturers related to the potential risk of exposure to non-dioxin-like (NDL) polychlorinated biphenyl acids (PC… |
| 2024-10-21 |
Class I
|
Ongoing |
Z-0378-2025 |
Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, Part Number R5C4482E; use in Peritoneal Dialysis |
— |
Baxter is aware of several recalls by other manufacturers related to the potential risk of exposure to non-dioxin-like (NDL) polychlorinated biphenyl acids (PC… |
| 2024-10-21 |
Class I
|
Ongoing |
Z-0377-2025 |
Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, Part Number R5C4482; use in Peritoneal Dialysis |
— |
Baxter is aware of several recalls by other manufacturers related to the potential risk of exposure to non-dioxin-like (NDL) polychlorinated biphenyl acids (PC… |
| 2024-10-21 |
Class I
|
Ongoing |
Z-0376-2025 |
Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, Part Number 5C4483; use in Peritoneal Dialysis |
— |
Baxter is aware of several recalls by other manufacturers related to the potential risk of exposure to non-dioxin-like (NDL) polychlorinated biphenyl acids (PC… |
| 2024-10-21 |
Class I
|
Ongoing |
Z-0375-2025 |
Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, Part Number 5C4482S; use in Peritoneal Dialysis |
— |
Baxter is aware of several recalls by other manufacturers related to the potential risk of exposure to non-dioxin-like (NDL) polychlorinated biphenyl acids (PC… |
| 2024-10-21 |
Class I
|
Ongoing |
Z-0374-2025 |
Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, Part Number 5C4482EJ; use in Peritoneal Dialysis |
— |
Baxter is aware of several recalls by other manufacturers related to the potential risk of exposure to non-dioxin-like (NDL) polychlorinated biphenyl acids (PC… |
| 2024-10-21 |
Class I
|
Ongoing |
Z-0373-2025 |
Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, Part Number 5C4482; use in Peritoneal Dialysis |
— |
Baxter is aware of several recalls by other manufacturers related to the potential risk of exposure to non-dioxin-like (NDL) polychlorinated biphenyl acids (PC… |
| 2024-10-16 |
Class I
|
Ongoing |
Z-0327-2025 |
Baxter AK 98 Dialysis Machine, Hemodialysis Delivery System, Product Code 955607. As of February 2025, the firm name is… |
— |
Baxter is aware of several recalls by other manufacturers related to the potential risk of exposure to non-dioxin-like (NDL) polychlorinated biphenyl acids (PCB… |
| 2024-10-11 |
Class II
|
Ongoing |
Z-0325-2025 |
Hillrom Welch Allyn XScribe Cardiac Stress Testing System; Programmable Diagnostic Computer |
— |
There is the potential for exam files being assigned duplicate Unique Identifiers (UIDs),. If the system receiving the DICOM file (e.g., Picture Archiving and … |
| 2024-10-11 |
Class II
|
Ongoing |
Z-0324-2025 |
Hillrom Welch Allyn Diagnostic Cardiology Suite (formerly Connex Cardio); Diagnostic spirometer |
— |
There is the potential for exam files being assigned duplicate Unique Identifiers (UIDs),. If the system receiving the DICOM file (e.g., Picture Archiving and … |
| 2024-10-11 |
Class II
|
Ongoing |
Z-0323-2025 |
Hillrom Welch Allyn Vision Express Holter Analysis System; Electrocardiograph |
— |
There is the potential for exam files being assigned duplicate Unique Identifiers (UIDs),. If the system receiving the DICOM file (e.g., Picture Archiving and … |
| 2024-10-11 |
Class II
|
Ongoing |
Z-0322-2025 |
Hillrom Welch Allyn RScribe 12-Lead Electrocardiograph System; Electrocardiograph |
— |
There is the potential for exam files being assigned duplicate Unique Identifiers (UIDs),. If the system receiving the DICOM file (e.g., Picture Archiving and … |
| 2024-10-11 |
Class II
|
Ongoing |
Z-0321-2025 |
Hillrom Welch Allyn Q-Stress Cardiac Stress Testing System; cardiac stress test |
— |
There is the potential for exam files being assigned duplicate Unique Identifiers (UIDs),. If the system receiving the DICOM file (e.g., Picture Archiving and … |
| 2024-10-11 |
Class II
|
Ongoing |
Z-0320-2025 |
Hillrom Welch Allyn HScribe Holter System; ambulatory monitoring |
— |
There is the potential for exam files being assigned duplicate Unique Identifiers (UIDs),. If the system receiving the DICOM file (e.g., Picture Archiving and … |
| 2024-10-02 |
Class II
|
Ongoing |
Z-0348-2025 |
Baxter Spectrum IQ Infusion System with Dose IQ Safety Software, Product Code 3570009 |
— |
The door on the Spectrum IQ Infusion pump may not be able to fully close. |
| 2024-09-19 |
Class II
|
Ongoing |
Z-0218-2025 |
Baxter Operating Table TruSystem 7000 U14 (MBW) V, Product code REF 2065386 |
— |
The firm received customer reports stating that the batteries and their connectors experienced electrical short-circuits and/or emitted smoke. |
| 2024-09-19 |
Class II
|
Ongoing |
Z-0217-2025 |
Baxter Operating Table TruSystem 7000 U14 (MBW), Product code REF 2065385 |
— |
The firm received customer reports stating that the batteries and their connectors experienced electrical short-circuits and/or emitted smoke. |
| 2024-09-19 |
Class II
|
Ongoing |
Z-0216-2025 |
Baxter Operating Table TruSystem 7000 (dV) V, Product code REF 1841083 |
— |
The firm received customer reports stating that the batteries and their connectors experienced electrical short-circuits and/or emitted smoke. |
| 2024-09-19 |
Class II
|
Ongoing |
Z-0215-2025 |
Baxter Operating Table TruSystem 7000 (MBW) V, Product code REF 1841082 |
— |
The firm received customer reports stating that the batteries and their connectors experienced electrical short-circuits and/or emitted smoke. |
| 2024-09-19 |
Class II
|
Ongoing |
Z-0214-2025 |
Baxter Operating Table TruSystem 7000 V, Product code REF 1841050 |
— |
The firm received customer reports stating that the batteries and their connectors experienced electrical short-circuits and/or emitted smoke. |
| 2024-09-19 |
Class II
|
Ongoing |
Z-0213-2025 |
Baxter Operating Table TruSystem 7000 (dV), Product code REF 1841049 |
— |
The firm received customer reports stating that the batteries and their connectors experienced electrical short-circuits and/or emitted smoke. |
| 2024-09-19 |
Class II
|
Ongoing |
Z-0212-2025 |
Baxter Operating Table TruSystem 7000 (MBW), Product code REF 1841048 |
— |
The firm received customer reports stating that the batteries and their connectors experienced electrical short-circuits and/or emitted smoke. |
| 2024-09-19 |
Class II
|
Ongoing |
Z-0211-2025 |
Baxter Operating Table TruSystem 7000, Product code REF 1841046 |
— |
The firm received customer reports stating that the batteries and their connectors experienced electrical short-circuits and/or emitted smoke. |
| 2024-09-19 |
Class II
|
Ongoing |
Z-0210-2025 |
Baxter Operating table TruSystem 7000 U (MB), Product codes: a) REF 1604786; b) REF 1604788; c) REF 1723633 |
— |
The firm received customer reports stating that the batteries and their connectors experienced electrical short-circuits and/or emitted smoke. |
| 2024-09-18 |
Class II
|
Ongoing |
Z-0228-2025 |
a. Hillrom Centrella Smart+ Medical-Surgical Hospital Bed, Product codes: P7900B000001, P7900B100010, P7900B100024, P7… |
— |
The beds have a potential for an interface issue with the Rauland Responder 5 Nurse Call System where the bed exit system will alert at the bed, but may fail to… |
| 2024-09-12 |
Class I
|
Ongoing |
Z-0046-2025 |
Welch Allyn Life2000 Ventilation System, REF MS-01-0118, within exterior carton codes: 1) BT-20-0002, 2) BT-20-0002A, 3… |
— |
The Life2000 ventilator may fail to initiate the Low Gas Pressure alarm if the pressure gas source (Life2000 compressor, oxygen cylinder or wall source) is not … |
| 2024-08-20 |
Class I
|
Ongoing |
Z-3085-2024 |
Baxter EXACTAMIX Inlet, Vented, Syringe Inlet, REF H938176, for use in a pharmaceutical compounding device |
— |
Baxter Healthcare Corporation has received increased customer reports of particulate matter in the Automated Compounding Device Inlets (disposable inlet), Produ… |
| 2024-08-20 |
Class I
|
Ongoing |
Z-3084-2024 |
Baxter EXACTAMIX Inlet, Vented, Micro-Volume Inlet, REF H938175, for use in a pharmaceutical compounding device |
— |
Baxter Healthcare Corporation has received increased customer reports of particulate matter in the Automated Compounding Device Inlets (disposable inlet), Produ… |
| 2024-08-20 |
Class I
|
Ongoing |
Z-3083-2024 |
Baxter EXACTAMIX Inlet, Vented, High Volume Inlet, REF H938174, for use in a pharmaceutical compounding device |
— |
Baxter Healthcare Corporation has received increased customer reports of particulate matter in the Automated Compounding Device Inlets (disposable inlet), Produ… |
| 2024-08-20 |
Class I
|
Ongoing |
Z-3082-2024 |
Baxter EXACTAMIX Inlet, Non-Vented, High Volume Inlet, REF H938173, for use in a pharmaceutical compounding device |
— |
Baxter Healthcare Corporation has received increased customer reports of particulate matter in the Automated Compounding Device Inlets (disposable inlet), Produ… |
| 2024-07-17 |
Class II
|
Ongoing |
Z-2582-2024 |
Spectrum Wireless Battery Modules A/B/G/N, product code 36010, used with either of the following 35700BAX2 (Spectrum V8 … |
— |
The Spectrum WBM may fail to auto-document infusion status information back to the hospital's Electronic Medical Record (EMR) system. This software issue only i… |
| 2024-07-17 |
Class II
|
Ongoing |
Z-2581-2024 |
Baxter Spectrum Wireless Battery Modules A/B/G/N, product code 35223, used with either of the following: 35700BAX2 (Spe… |
— |
The Spectrum WBM may fail to auto-document infusion status information back to the hospital's Electronic Medical Record (EMR) system. This software issue only i… |
| 2024-06-28 |
Class II
|
Ongoing |
Z-2512-2024 |
Baxter PST 500 U, Precision Surgical Table, Part number (product code) 4080300 |
— |
Baxter Healthcare Corporation is issuing an Urgent Medical Device Correction for the PST 500 U Precision Surgical Table due to a potential issue with loose spri… |
| 2024-06-14 |
Class II
|
Ongoing |
Z-2530-2024 |
Baxter SIGMA Spectrum Infusion Pump, Product Code: 35700BAX2 |
— |
Improperly performed testing prior to release |
| 2024-06-13 |
Class II
|
Ongoing |
Z-2339-2024 |
Braun Thermoscan¿ PRO 6000 Ear Thermometer |
— |
The Braun Thermoscan PRO 6000 ear thermometers may have been shipped with a compact disc (CD) containing an outdated version of the Instructions for Use (IFU). |
| 2024-06-04 |
Class II
|
Ongoing |
Z-2315-2024 |
iLED 7 surgical lights, Model Numbers: a) 4068110 (Ceiling Single Surgical Light); b) 4068120 (Mobile Surgical Ligh… |
— |
Baxter Healthcare Corporation is issuing an Urgent Medical Device Correction due to customer reports of thermal skin injuries when using the iLED 7 surgical lig… |
| 2024-06-04 |
Class II
|
Ongoing |
Z-2314-2024 |
Trulight 5000/3000 Surgical Light, model numbers: a) 4038210 (Duo Surgical Lights}; b) 4038310 (Trio/Quad Surgical … |
— |
Baxter Healthcare Corporation is issuing an Urgent Medical Device Correction due to customer reports of thermal skin injuries when using the iLED 7 surgical lig… |
| 2024-06-04 |
Class II
|
Ongoing |
Z-2313-2024 |
VidiaPort carrying arm, mount for auxiliary products, model numbers: a) 4028110 (Ceiling Single Surgical Light); b)… |
— |
Baxter Healthcare Corporation is issuing an Urgent Medical Device Correction due to customer reports of thermal skin injuries when using the iLED 7 surgical lig… |
| 2024-06-03 |
Class II
|
Ongoing |
Z-2323-2024 |
Welch Allyn CP150 Electrocardiograph with Spirometry Option, Product Code: CP150A-1ENB. The Electrocardiograph is one of… |
— |
During manufacturing, the step to install an Electromagnetic Interference (EMI) Absorber was omitted. The purpose of the EMI absorber is to prevent EMI leakage … |
| 2024-05-30 |
Class I
|
Ongoing |
Z-2322-2024 |
Volara System. Blue Ventilator Adapter Module. Intermittent positive pressure breathing device component. |
— |
Potential of the handset plug to disconnect from the nebulizer port on the blue ventilator adapter. The handset plug is required to ensure proper operation and… |
| 2024-05-30 |
Class I
|
Ongoing |
Z-2321-2024 |
Volara System. Single Patient Use (SPU) Circuit 5kit for Volara and Single Patient Use (SPU) Circuit kit for Volara. In… |
— |
Potential of the handset plug to disconnect from the nebulizer port on the blue ventilator adapter. The handset plug is required to ensure proper operation and… |
| 2024-05-29 |
Class I
|
Ongoing |
Z-2140-2024 |
Life2000 Ventilator, Product Code: MS-01-0118, which is contained in the Life2000 Ventilator System, with Product Codes … |
— |
Potential for certain Life2000 ventilator systems to either fail to charge or have intermittent charging behavior due to damage to the battery charger dongle. D… |
| 2024-05-08 |
Class II
|
Ongoing |
Z-2151-2024 |
Centrella Max - The Centrella Smart+ Bed is intended for use in healthcare environments as a patient support system to p… |
— |
There is a potential for the top cover of the hospital bed mattress to delaminate as a result of improper cleaning and lack of adequate details on the appropria… |
| 2024-04-09 |
Class II
|
Ongoing |
Z-1810-2024 |
Spectrum IQ Infusion pump, Product Code 357009 |
— |
There is a potential for cracks on the mount of the front panel of the device. |
| 2024-03-26 |
Class II
|
Ongoing |
Z-1511-2024 |
Power Cords, marketed under the following models: a) CORD,METAL EARTH PIN, 2.5A,250V,2.5M,C7, 714682; b) PLFM CLASS… |
— |
Baxter received reports of an issue related to the construction of the power cord not meeting the insulation rating per country-specific requirements and intern… |
| 2024-03-26 |
Class II
|
Ongoing |
Z-1510-2024 |
Hillrom Welch Allyn Spot Vision Screener VS100, marketed under the following models: a) SPOT VISION SCREENER,W/O CASE… |
— |
Baxter received reports of an issue related to the construction of the power cord not meeting the insulation rating per country-specific requirements and intern… |
| 2024-03-26 |
Class II
|
Ongoing |
Z-1509-2024 |
Hillrom Welch Allyn Connex ProBP 3400 Digital Blood Pressure Device, marketed under the following models: a) PROBP 34… |
— |
Baxter received reports of an issue related to the construction of the power cord not meeting the insulation rating per country-specific requirements and intern… |
| 2024-03-20 |
Class II
|
Ongoing |
Z-1775-2024 |
Baxter Spectrum IQ Infusion Pump, Product Code 3570009 |
— |
One device was improperly performed testing prior to release from a Service Center. |
| 2024-03-15 |
Class II
|
Ongoing |
Z-1689-2024 |
Baxter Seprafilm Adhesion Barrier 1 Half Sheet, 5-PK, REF 664103, for use in abdominal and pelvic surgery |
— |
Product was distributed in the United States without proper regulatory approval. |
| 2024-03-11 |
Class II
|
Ongoing |
Z-1329-2024 |
HDS Traction Boot II, REF AR-6529-23, The Traction Boot is designed to position, support and/or distract the patient's f… |
— |
Baxter Healthcare Corporation is issuing an Urgent Medical Device Recall for the Hip Distraction System, Traction Boot II, due to the boots being assembled inco… |
| 2024-03-05 |
Class II
|
Ongoing |
Z-1400-2024 |
Hill-Rom PRO+ 36" MRS Surface, REF P7924A03, The pro+ mattress is intended for patient support and for the prevention an… |
— |
Inconsistencies were identified with service records associated with corrections performed for a previous Medical Device Correction issued by Baxter (ref number… |
| 2024-02-28 |
Class II
|
Ongoing |
Z-1380-2024 |
Baxter Supple Peri-Guard Repair Patch (new product codes): a) SPG0404, b) SPG0406, c) SPG0608, d) SPG0814, e)… |
— |
A new contraindication was added to the IFU which states that Peri-Guard Repair Patch should not be used in neurosurgery since the product endotoxin level may … |
| 2024-02-28 |
Class II
|
Ongoing |
Z-1379-2024 |
Baxter Peri-Guard Repair Patch (new product codes): a) PG0404, b) PG0608, c) PG0814, d) PG1016, e) PG1225 |
— |
A new contraindication was added to the IFU which states that Peri-Guard Repair Patch should not be used in neurosurgery since the product endotoxin level may … |
| 2024-02-28 |
Class II
|
Ongoing |
Z-1378-2024 |
Baxter Supple Peri-Guard Repair Patch (legacy product codes): a) PC0404SNBIO, b) PC0608NSBIO, c) PC0814SNBIO, d)… |
— |
A new contraindication was added to the IFU which states that Peri-Guard Repair Patch should not be used in neurosurgery since the product endotoxin level may … |
| 2024-02-28 |
Class II
|
Ongoing |
Z-1377-2024 |
Baxter Peri-Guard Repair Patch (legacy product codes): a) PC0404NBIO, b) PC0608NBIO, c) PC0814NBIO, d) PC1016NBI… |
— |
A new contraindication was added to the IFU which states that Peri-Guard Repair Patch should not be used in neurosurgery since the product endotoxin level may … |
| 2024-02-22 |
Class II
|
Ongoing |
Z-1524-2024 |
Surgical Tools and Cardiovascular Specialty marketing brochures, Reference numbers: US-AS18-210002 Surgical Tools Broch… |
— |
The Surgical Tools and Cardiovascular Specialty marketing brochures distributed for Flo-Rester Disposable Internal Vessel Occluder, Flo-Thru Intraluminal Shunt,… |
| 2024-02-22 |
Class II
|
Ongoing |
Z-1523-2024 |
Surgical Tools and Cardiovascular Specialty marketing brochures, Reference numbers: US-AS18-210002 Surgical Tools Broch… |
— |
The Surgical Tools and Cardiovascular Specialty marketing brochures distributed for Flo-Rester Disposable Internal Vessel Occluder, Flo-Thru Intraluminal Shunt,… |
| 2024-02-22 |
Class II
|
Ongoing |
Z-1522-2024 |
Surgical Tools and Cardiovascular Specialty marketing brochures, Reference numbers: US-AS18-210002 Surgical Tools Broch… |
— |
The Surgical Tools and Cardiovascular Specialty marketing brochures distributed for Flo-Rester Disposable Internal Vessel Occluder, Flo-Thru Intraluminal Shunt,… |
| 2024-02-14 |
Class II
|
Ongoing |
Z-1289-2024 |
STERIS Boot Assembly, Traction Device, OT 1000, Part Number REF 10009192 |
— |
Three lots of the Boot Assembly, Traction Device are being recalled due to due to a customer report of an incorrectly oriented locking pin which caused the boot… |
| 2024-02-08 |
Class II
|
Ongoing |
Z-1291-2024 |
CLEARLINK Non-DEHP Solution Set Luer Lock Adapter, Product Code 2R8401 |
— |
Baxter Healthcare Corporation is issuing an Urgent Medical Device Recall for the Clearlink Non-DEHP solution set listed below due to potential leaks originating… |
| 2023-12-22 |
Class I
|
Ongoing |
Z-1002-2024 |
Baxter Exactamix Pro 2400, REF EXM24DY |
— |
An error was identified in software versions 2.0.8 and 2.1.8 while using the "Use Some Overfill" feature which may lead to over-delivery of an ingredient. This … |
| 2023-12-22 |
Class I
|
Ongoing |
Z-1001-2024 |
Baxter Exactamix Pro 1200, REF EXM12DY |
— |
An error was identified in software versions 2.0.8 and 2.1.8 while using the "Use Some Overfill" feature which may lead to over-delivery of an ingredient. This … |
| 2023-12-08 |
Class II
|
Ongoing |
Z-0707-2024 |
XScribe CP Cardiac Stress Testing System, version 6, with below product names and codes: a) X-SCRIBE CPI KIT WIRELESS US… |
— |
Potential distortion identified in electrocardiogram (ECG) readings when the Source Consistency Filter (SCF) is enabled. |
| 2023-12-08 |
Class II
|
Ongoing |
Z-0706-2024 |
XScribe Cardiac Stress Testing System, version 6, with below product names and codes: a) XS6/RS6 REVIEW WKSTN KIT, XR-6A… |
— |
Potential distortion identified in electrocardiogram (ECG) readings when the Source Consistency Filter (SCF) is enabled. |
| 2023-12-08 |
Class II
|
Ongoing |
Z-0705-2024 |
Q-Stress Cardiac Stress Testing System, version 6, with below product name / product codes: a) QS6 AM12Q KIT AHA XML / Q… |
— |
Potential distortion identified in electrocardiogram (ECG) readings when the Source Consistency Filter (SCF) is enabled. |
| 2023-12-06 |
Class II
|
Ongoing |
Z-0669-2024 |
Vascu-Guard Peripheral Vascular Patch (GLOBAL), Product Codes: a) VG0108N: 0.8X8 CM GLOBAL, b) VG0110N: 1X10 CM G… |
— |
Cardiovascular Surgery marketing brochure (US-AS46-220001) that was distributed for the products listed below contains inaccurate content that does not align wi… |
| 2023-12-06 |
Class II
|
Ongoing |
Z-0668-2024 |
PERI-GUARD SUPPLE, Product Codes: a) SPG1016: 10X16 CM US, TS; b) SPG0404: 4 X 4 CM US, TS; c) SPG0608: 6 X 8 … |
— |
Cardiovascular Surgery marketing brochure (US-AS46-220001) that was distributed for the products listed below contains inaccurate content that does not align wi… |
| 2023-12-06 |
Class II
|
Ongoing |
Z-0667-2024 |
Baxter FloSeal Hemostatic Matrix NL, 5 mL, Product Codes: ADS201883 |
— |
Cardiovascular Surgery marketing brochure (US-AS46-220001) that was distributed for the products listed below contains inaccurate content that does not align wi… |
| 2023-12-06 |
Class II
|
Ongoing |
Z-0666-2024 |
Vascu-Guard Peripheral Vascular Patch (US), Product Codes: a) VG0108: 0.8 X 8 CM US, TS; b) VG0110: 1 X 10 CM US, T… |
— |
Cardiovascular Surgery marketing brochure (US-AS46-220001) that was distributed for the products listed below contains inaccurate content that does not align wi… |
| 2023-12-06 |
Class II
|
Ongoing |
Z-0665-2024 |
Peri-Guard Repair Patch, Product Codes: a) PC1016NBIO: 10X16CMUS, b) PC1225NBIO: 12X25CMUS, c) PC0404NBIO: 4X4CM… |
— |
Cardiovascular Surgery marketing brochure (US-AS46-220001) that was distributed for the products listed below contains inaccurate content that does not align wi… |
| 2023-12-06 |
Class II
|
Ongoing |
Z-0664-2024 |
Peri-Guard Repair Patch, Product Codes: a) PG1016 : 10 X 16 CMUS, TS b) PG1225: 12 X 25 CMUS, TS c) PG0404: 4 X 4… |
— |
Cardiovascular Surgery marketing brochure (US-AS46-220001) that was distributed for the products listed below contains inaccurate content that does not align wi… |
| 2023-12-06 |
Class II
|
Ongoing |
Z-0663-2024 |
Baxter Flo-Thru Intraluminal Shunt, Product Codes: a) Product Code FT12100, 1.00 GLOBAL; b) Product Code FT12125, 1.… |
— |
Cardiovascular Surgery marketing brochure (US-AS46-220001) that was distributed for the products listed below contains inaccurate content that does not align wi… |
| 2023-12-06 |
Class II
|
Ongoing |
Z-0662-2024 |
Baxter FloSeal Hemostatic Matrix RECOTHROM, Product Codes: a) ADS202105, 5mL-6 PK US b) ADS202110, 10mL US |
— |
Cardiovascular Surgery marketing brochure (US-AS46-220001) that was distributed for the products listed below contains inaccurate content that does not align wi… |
| 2023-12-06 |
Class II
|
Ongoing |
Z-0661-2024 |
Baxter Floseal Hemostatic Matrix Fast Prep, Product Codes: a) ADS201844, 5 mL b) ADS201845, 10mL |
— |
Cardiovascular Surgery marketing brochure (US-AS46-220001) that was distributed for the products listed below contains inaccurate content that does not align wi… |
| 2023-12-06 |
Class II
|
Ongoing |
Z-0660-2024 |
Baxter Preveleak Surgical Sealant, Product Codes: ADS201808 |
— |
Cardiovascular Surgery marketing brochure (US-AS46-220001) that was distributed for the products listed below contains inaccurate content that does not align wi… |
| 2023-12-06 |
Class II
|
Ongoing |
Z-0659-2024 |
Baxter Vascular Probe, Product Codes: a) 7081015: 8CM, 1- 1.5 MM GLOBAL, b) 7081520: 8CM, 1.5-2 MM GLOBAL, c)… |
— |
Cardiovascular Surgery marketing brochure (US-AS46-220001) that was distributed for the products listed below contains inaccurate content that does not align wi… |
| 2023-12-06 |
Class II
|
Ongoing |
Z-0658-2024 |
Baxter Ostene Hemostasis Material, Product Codes: a) 1503831, 3.5 G; b) 1503832, 2.5 G; c) 1503833, 1.0 G |
— |
Cardiovascular Surgery marketing brochure (US-AS46-220001) that was distributed for the products listed below contains inaccurate content that does not align wi… |
| 2023-12-06 |
Class II
|
Ongoing |
Z-0657-2024 |
Baxter Coseal Premix, Surgical Sealant, Product Codes: a) 934070; b) 934071; c) 934072 |
— |
Cardiovascular Surgery marketing brochure (US-AS46-220001) that was distributed for the products listed below contains inaccurate content that does not align wi… |
| 2023-12-06 |
Class II
|
Ongoing |
Z-0656-2024 |
Baxter Flo-Rester, Disposable internal vessel occluder, distributed in the following sizes: a) Product Code 50100: 12M… |
— |
Cardiovascular Surgery marketing brochure (US-AS46-220001) that was distributed for the products listed below contains inaccurate content that does not align wi… |
| 2023-11-15 |
Class II
|
Ongoing |
Z-0550-2024 |
Baxter Amia Automated Peritoneal Dialysis (APD) Cycler Set, REF 5C5479 |
— |
There is to an increase in complaints related to failure alarms for Wet Cassette Integrity Test occurring on the Amia devices. |
| 2023-10-13 |
Class I
|
Ongoing |
Z-0151-2024 |
Novum IQ Syringe infusion system, Product Code 40800BAXUS |
— |
Baxter is issuing an Urgent Medical Device Correction for the Novum IQ Syringe Pump. Baxter identified that after multiple downstream occlusion alarms, the pump… |
| 2023-10-04 |
Class II
|
Ongoing |
Z-0212-2024 |
HILLROM PROGRESSA+ BED, Product Codes: P7501A000016, P7501A000019, P7501A000031, P7501A000032, P7501A000033, P7501A0000… |
— |
Progressa+ beds have the potential for static buildup from the casters and/or power drive. This static electricity could be passed to the operator through the t… |
| 2023-08-10 |
Class II
|
Ongoing |
Z-2647-2023 |
Baxter Epiphany Cardio Server E3 ECG Management System Servers with software versions: a) v6.1.x, b) v6.2.x, c) v7.0.x. |
— |
Epiphany, now a Baxter Healthcare company, is issuing an Urgent Medical Device Correction for the Cardio Server E3 ECG Management System software listed below d… |
| 2023-08-10 |
Class II
|
Ongoing |
Z-2581-2023 |
Welch Allyn Connex Spot Monitor |
— |
Product is being recalled due to the improper placement of a copper tape on the back of the liquid-crystal display. |
| 2023-06-19 |
Class II
|
Ongoing |
Z-2208-2023 |
GEM FLOW COUPLER Monitor, PN 5156-00000-011 |
— |
An issue was identified where the LCD monitor display may not indicate the correct active channel. The issue occurs when the monitor is turned on using battery … |
| 2023-06-15 |
Class I
|
Ongoing |
Z-2104-2023 |
The Spectrum IQ Infusion System with Dose IQ Safety Software, Product Code 3570009 |
— |
A medical device correction is being issued for SIGMA Spectrum Infusion System (V8 Platform) and Spectrum IQ Infusion System with Dose IQ Safety Software infusi… |
| 2023-06-15 |
Class I
|
Ongoing |
Z-2103-2023 |
SIGMA Spectrum Infusion Pump, Product Code 35700BAX2 |
— |
A medical device correction is being issued for SIGMA Spectrum Infusion System (V8 Platform) and Spectrum IQ Infusion System with Dose IQ Safety Software infusi… |
| 2023-05-19 |
Class II
|
Ongoing |
Z-2007-2023 |
NaviCare Patient Safety V3.9.200 to 3.9.600, used with the Centrella Bed |
— |
Baxter identified a potential risk where the "safety" monitoring and "bed exit" monitoring features may enter a permanent state of alert suppression. In this st… |
| 2023-05-19 |
Class II
|
Ongoing |
Z-2006-2023 |
Voalte Patient Safety, Part Number 4.0, V4.0.000 to 4.0.401, used with the Centrella Bed |
— |
Baxter identified a potential risk where the "safety" monitoring and "bed exit" monitoring features may enter a permanent state of alert suppression. In this st… |
| 2023-05-18 |
Class II
|
Ongoing |
Z-2109-2023 |
Allen Advance Chest Support with Pad |
— |
Potential for the device to crack where the Chest Base Prone support attaches to the carbon fiber operating room (OR) table rail. |
| 2023-03-31 |
Class II
|
Ongoing |
Z-1482-2023 |
Hill-Rom pro+ mattress, product codes (REF): a) 20877002S, b) 20877003S, c) 20877004S, d) 20877007S, e) 20877008S, f) 2… |
— |
There is a potential for mattress cover damage (delamination) which may result in fluid absorption in the mattress (fluid ingress). |
| 2023-03-27 |
Class II
|
Ongoing |
Z-1461-2023 |
GEM NEUROTUBE, Absorbable Woven Polyglycolic Acid Mesh Tube, Product Codes: a) 5311-01240-010, b) 5311-01240-012; for… |
— |
The product is brittle and potentially crumbling upon handling or when being removed from its package. |
| 2023-03-20 |
Class II
|
Ongoing |
Z-1420-2023 |
ExactaMed Oral Dispenser - 20 mL Clear Pharmacy Pack, REF H9387120; Oral medication syringe |
— |
ExataMed 20 mL oral dispenser component of the Clear Pharmacy Pack may have particulate matter. |
| 2023-02-22 |
Class II
|
Ongoing |
Z-1316-2023 |
Automated Peritoneal Dialysis System. Used for automatic control of dialysis solution exchanges. |
— |
The electrical safety testing was not properly performed on the impacted devices and additional testing is required |
| 2023-02-01 |
Class II
|
Ongoing |
Z-1213-2023 |
Baxter MiniCap Disconnect Cap with Povidone-Iodine Solution, 5C4466P; Accessory to disposable administration set for per… |
— |
MiniCap Disconnect Cap with Povidone-Iodine are packaged in foil pouches, which may have been incorrectly sealed, i.e., the pouches may have open or weak seals.… |
| 2023-01-25 |
Class I
|
Ongoing |
Z-1142-2023 |
Life2000 Ventilator , REF MS-01-0118, ventilatory support for the care of individuals |
— |
There is the potential for patient desaturation events to occur under certain scenarios when the Life2000 ventilation system is connected with an oxygen concent… |
| 2023-01-25 |
Class I
|
Ongoing |
Z-1141-2023 |
Life2000 Ventilator PKG, Hospital, a) REF BT200011, b) REF BT-20-0011, ventilatory support for the care of individuals |
— |
There is the potential for patient desaturation events to occur under certain scenarios when the Life2000 ventilation system is connected with an oxygen concent… |
| 2023-01-25 |
Class I
|
Ongoing |
Z-1140-2023 |
Life2000 Ventilator PKG, Hospital, a) REF BT20007, b) REF BT-20-0007, ventilatory support for the care of individuals |
— |
There is the potential for patient desaturation events to occur under certain scenarios when the Life2000 ventilation system is connected with an oxygen concent… |
| 2023-01-25 |
Class I
|
Ongoing |
Z-1139-2023 |
Life2000 Ventilator System, a) REF BT-20-0002, b) REF BT-20-0002A, ventilatory support for the care of individuals |
— |
There is the potential for patient desaturation events to occur under certain scenarios when the Life2000 ventilation system is connected with an oxygen concent… |
| 2022-11-23 |
Class II
|
Ongoing |
Z-0764-2023 |
Revaclear 400 dialyzers. Indicated for treatment of chronic and acute renal failure by hemodialysis. |
— |
Reports of Polyurethane Displacement in the dialyzer, and might be identified as a blood leak |
| 2022-11-23 |
Class II
|
Ongoing |
Z-0763-2023 |
Revaclear 400 dialyzers. Indicated for treatment of chronic and acute renal failure by hemodialysis. |
— |
Reports of Polyurethane Displacement in the dialyzer, and might be identified as a blood leak |
| 2022-11-23 |
Class II
|
Ongoing |
Z-0762-2023 |
Revaclear 300 dialyzers. Indicated for treatment of chronic and acute renal failure by hemodialysis. |
— |
Reports of Polyurethane Displacement in the dialyzer, and might be identified as a blood leak |
| 2022-11-23 |
Class II
|
Ongoing |
Z-0761-2023 |
Revaclear 400 Dialyzer. Product Code: 114749M. Not distributed in the USA. Used to treat chronic and acute renal fa… |
— |
Potential for Internal Blood Leaks due to a twisted gasket in the dialyzer |
| 2022-11-23 |
Class II
|
Ongoing |
Z-0760-2023 |
Revaclear 400 Dialyzer. Product Code: 114746L. Used to treat chronic and acute renal failure by hemodialysis. |
— |
Potential for Internal Blood Leaks due to a twisted gasket in the dialyzer |
| 2022-10-31 |
Class II
|
Terminated |
Z-1013-2023 |
Baxter Electrocardiograph, ELI 380 -DCS21 |
— |
One ELI 380 Electrocardiograph intended to be used for a pilot program was shipped to a customer by mistake on 26 October 2022. |
| 2022-10-18 |
Class II
|
Ongoing |
Z-0231-2023 |
Hill-Rom Progressa Bed System |
— |
The compression links on impacted Progressa beds, listed in Appendix A, may bend when raising the head section. The labeling for these beds list a maximum patie… |
| 2022-09-30 |
Class I
|
Ongoing |
Z-0145-2023 |
Hillrom Hospital Bed Accessory, Watch Care Incontinence Management System for VersaCare Bed Rev. A-J, Product Code/Part … |
— |
Radio frequency emission from a functioning WatchCare device may potentially impact other devices (including, but not limited to telemetry devices, bladder scan… |
| 2022-09-30 |
Class I
|
Ongoing |
Z-0144-2023 |
Hillrom Hospital Bed Accessory, WatchCare Incontinence Management System for VersaCare Bed Rev. K, Product Code/Part Num… |
— |
Radio frequency emission from a functioning WatchCare device may potentially impact other devices (including, but not limited to telemetry devices, bladder scan… |
| 2022-09-30 |
Class I
|
Ongoing |
Z-0143-2023 |
Hillrom Hospital Bed Accessory, Watch Care Incontinence Management System for Progressa Bed, Product Code/Part Number P0… |
— |
Radio frequency emission from a functioning WatchCare device may potentially impact other devices (including, but not limited to telemetry devices, bladder scan… |
| 2022-09-30 |
Class I
|
Ongoing |
Z-0142-2023 |
Hillrom Hospital Bed Accessory, Watch Care Incontinence Management System for Centrella Bed, Product Code/Part Number P0… |
— |
Radio frequency emission from a functioning WatchCare device may potentially impact other devices (including, but not limited to telemetry devices, bladder scan… |
| 2022-09-30 |
Class I
|
Ongoing |
Z-0141-2023 |
Hillrom Centrella Hospital Bed with WatchCare Incontinence Management System, Product code/Part numbers: P7900B100193, … |
— |
Radio frequency emission from a functioning WatchCare device may potentially impact other devices (including, but not limited to telemetry devices, bladder scan… |
| 2022-09-20 |
Class II
|
Ongoing |
Z-0180-2023 |
Simple Clamp, US/EURO Rails, UPPER EXTREMITY DISTRACTION CMPT, REF F-40018, #800101. To position, support and/or distra… |
— |
the adhesive, applied to screws and bolts as an additional holding force, may not cure correctly, and as a result, could result in a loss of holding and reduced… |
| 2022-09-20 |
Class II
|
Ongoing |
Z-0179-2023 |
Allen Life Assist Beach Chair, BCSSP-BEACH CHAIR , REF A-91501, #104002. For use with orthopaedic procedures using the … |
— |
the adhesive, applied to screws and bolts as an additional holding force, may not cure correctly, and as a result, could result in a loss of holding and reduced… |
| 2022-09-20 |
Class II
|
Ongoing |
Z-0178-2023 |
Beach Chair Clamp, BEACH CHAIR SHLDER POSITIONER CMPT, REF A-90013, #800104. Component to position and support the pat… |
— |
the adhesive, applied to screws and bolts as an additional holding force, may not cure correctly, and as a result, could result in a loss of holding and reduced… |
| 2022-09-20 |
Class II
|
Ongoing |
Z-0177-2023 |
Allen Standard Starburst, Mayfield/Doro, STANDARD SPINE POSITIONERS CMPT, REF A-70710, #800103. Component to position… |
— |
the adhesive, applied to screws and bolts as an additional holding force, may not cure correctly, and as a result, could result in a loss of holding and reduced… |
| 2022-09-20 |
Class II
|
Ongoing |
Z-0176-2023 |
C-Flex Polar Head Positnr-Device Only, SSP-NEUROSURGICAL HEADREST, REF A-70701, #103001, |
— |
the adhesive, applied to screws and bolts as an additional holding force, may not cure correctly, and as a result, could result in a loss of holding and reduced… |
| 2022-09-20 |
Class II
|
Ongoing |
Z-0175-2023 |
Allen Advance Table, RSP-ADVANCE TABLE: a) REF A-71100-US, #107003, b) A-71101-EU, #107003. operating room table |
— |
the adhesive, applied to screws and bolts as an additional holding force, may not cure correctly, and as a result, could result in a loss of holding and reduced… |
| 2022-09-14 |
Class II
|
Ongoing |
Z-0085-2023 |
Prismaflex HF20 Set (product code 109841). For use in providing continuous fluid management and renal replacement thera… |
— |
Within the current Prismaflex set IFU (instructions for use), there is a mistranslation of the Extonian (Eesti) text. The mistranslation indicates contradictor… |
| 2022-09-14 |
Class II
|
Ongoing |
Z-0084-2023 |
Prismaflex ST Set: ST60 (product code 107643), ST100 (product code 107636), ST150 (product code 107640). For use in pr… |
— |
Within the current Prismaflex set IFU (instructions for use), there is a mistranslation of the Extonian (Eesti) text. The mistranslation indicates contradictor… |
| 2022-09-14 |
Class II
|
Ongoing |
Z-0083-2023 |
Prismaflex HF Set: HF1000 (product code 107140), HF1400 (product code 107142). For use in providing continuous fluid m… |
— |
Within the current Prismaflex set IFU (instructions for use), there is a mistranslation of the Extonian (Eesti) text. The mistranslation indicates contradictor… |
| 2022-09-14 |
Class II
|
Ongoing |
Z-0082-2023 |
Prismaflex M Set: M150 (product code 109990). For use in providing continuous fluid management and renal replacement t… |
— |
Within the current Prismaflex set IFU (instructions for use), there is a mistranslation of the Extonian (Eesti) text. The mistranslation indicates contradictor… |
| 2022-09-14 |
Class II
|
Ongoing |
Z-0081-2023 |
Prismaflex M Set: M60 (product code 106696), M100 (product code 106697). For use in providing continuous fluid managem… |
— |
Within the current Prismaflex set IFU (instructions for use), there is a mistranslation of the Extonian (Eesti) text. The mistranslation indicates contradictor… |
| 2022-09-02 |
Class III
|
Ongoing |
Z-1817-2022 |
Starling Monitor, Product code CMMST5 and Starling Monitor SV, Product code CMM-ST5 (same products); and accessories/sp… |
— |
Labeling has incorrect or incomplete Unique Device Identification (UDI) information; and the barcodes are not compliant with GS-1 standards. |
| 2022-08-09 |
Class I
|
Terminated |
Z-1653-2022 |
Baxter CLEARLINK System, Non-DEHP Solution Set with DUO-VENT Spike, Product Code 2R8403. An in-line injection site. |
— |
Firm noted an increase in customer reports of leaks. |
| 2022-07-22 |
Class II
|
Ongoing |
Z-1581-2022 |
Baxter DISCPAC Syringe Tip Caps, Self-Righting, Luer Slip, Purple, 100 pack, REF H938677100 |
— |
There is a potential of the packaging not maintaining a sterile barrier for the tip caps. |
| 2022-07-22 |
Class II
|
Ongoing |
Z-1580-2022 |
Baxter DISCPAC Syringe Tip Caps, Self-Righting, Luer Slip, Pink, 100 pack, REF H938676100 |
— |
There is a potential of the packaging not maintaining a sterile barrier for the tip caps. |
| 2022-07-22 |
Class II
|
Ongoing |
Z-1579-2022 |
Baxter DISCPAC Syringe Tip Caps, Self-Righting, Luer Slip, Green: a) 25 pack, REF H93869025, b) 100 pack, REF H938674100… |
— |
There is a potential of the packaging not maintaining a sterile barrier for the tip caps. |
| 2022-07-22 |
Class II
|
Ongoing |
Z-1578-2022 |
Baxter DISCPAC Syringe Tip Caps, Self-Righting, Luer Slip, Dark Blue: a) 25 pack REF H938693025, b) 100 pack REF H938673… |
— |
There is a potential of the packaging not maintaining a sterile barrier for the tip caps. |
| 2022-07-22 |
Class II
|
Ongoing |
Z-1577-2022 |
Baxter DISCPAC Syringe Tip Caps, Self-Righting, Luer Slip, White REF H938671100 |
— |
There is a potential of the packaging not maintaining a sterile barrier for the tip caps. |
| 2022-07-22 |
Class II
|
Ongoing |
Z-1576-2022 |
Baxter DISCPAC Syringe Tip Caps, Self-Righting, Luer Slip, Orange: a) 25 pack, REF H93867025, b) 100 pack, REF H93867100 |
— |
There is a potential of the packaging not maintaining a sterile barrier for the tip caps. |
| 2022-07-22 |
Class II
|
Ongoing |
Z-1575-2022 |
Baxter DISCPAC Syringe Tip Caps, Self-Righting, Luer Slip, Yellow: a) 25 pack, REF H93866025, b) 100 pack, REF H93866100… |
— |
There is a potential of the packaging not maintaining a sterile barrier for the tip caps. |
| 2022-07-14 |
Class II
|
Ongoing |
Z-1570-2022 |
The Exacta-Mix 2400 compounding system, manufactured by Baxter Healthcare Corporation, is a compounding device used in t… |
— |
There is a potential for leaking valves on ports 1 to 4 in certain lots of valve sets. |
| 2022-06-24 |
Class II
|
Ongoing |
Z-1417-2022 |
Hill-Rom Centrella Pro+ 40" Surface mattress, REF P7923A04. |
— |
The failure mode on the affected mattresses can cause a reduction in the performance of the Microclimate Management feature used to pull heat and moisture away … |
| 2022-06-24 |
Class II
|
Ongoing |
Z-1416-2022 |
Hill-Rom Centrella Pro+ 36" Surface mattress, REF P7923A03. |
— |
The failure mode on the affected mattresses can cause a reduction in the performance of the Microclimate Management feature used to pull heat and moisture away … |
| 2022-06-24 |
Class II
|
Ongoing |
Z-1415-2022 |
Hill-Rom Centrella Pro+ 36" Surface With X-Ray mattress, REF P7923A01. |
— |
The failure mode on the affected mattresses can cause a reduction in the performance of the Microclimate Management feature used to pull heat and moisture away … |
| 2022-06-24 |
Class II
|
Ongoing |
Z-1414-2022 |
Hill-Rom PRO+ MRS Surface For Versacare mattress, REF P3255A02. |
— |
The failure mode on the affected mattresses can cause a reduction in the performance of the Microclimate Management feature used to pull heat and moisture away … |
| 2022-06-24 |
Class II
|
Ongoing |
Z-1413-2022 |
Hill-Rom PRO+ MRS Surface For Versacare With X-Ray mattress, REF P3255A01. |
— |
The failure mode on the affected mattresses can cause a reduction in the performance of the Microclimate Management feature used to pull heat and moisture away … |
| 2022-06-24 |
Class II
|
Ongoing |
Z-1412-2022 |
Hill-Rom PRO+ 36" MRS Surface mattress, REF P7924A03. |
— |
The failure mode on the affected mattresses can cause a reduction in the performance of the Microclimate Management feature used to pull heat and moisture away … |
| 2022-06-24 |
Class II
|
Ongoing |
Z-1411-2022 |
Hill-Rom PRO+ 36" MRS Surface With X-Ray mattress, REF P7924A01; and REF P7924ARENT01, PRO+ MRS Rental Surface with X-R… |
— |
The failure mode on the affected mattresses can cause a reduction in the performance of the Microclimate Management feature used to pull heat and moisture away … |
| 2022-06-22 |
Class I
|
Terminated |
Z-1376-2022 |
ABACUS TPN (Total Parenteral Nutrition) Calculation software, Product codes: 8300-0167 (Abacus V3.1 CE), 8300-0168 (Aba… |
— |
There is a potential risk of medication error when using specific Abacus Order Entry & Calculation software. |
| 2022-05-31 |
Class II
|
Ongoing |
Z-1306-2022 |
NaviCare Nurse Call/Voalte Nurse Call |
— |
An issue has been identified with Phillips (Emergin) and Longleaf non relay (Connexall, Vocera, Cerner) wireless integrations used with NaviCare/Voalte Nurse Ca… |
| 2022-05-17 |
Class II
|
Terminated |
Z-1288-2022 |
#1 MAC F/O LARYNGOSCOPE; F/O Laryngoscope Set-MAC; F/O Laryngoscope Set-MAC W/LED |
— |
Packaging error. |
| 2022-04-26 |
Class I
|
Terminated |
Z-1139-2022 |
In-Line ventilator adaptor |
— |
There is a potential of reduced oxygenation or pneumothorax/barotrauma to occur when the Volara system is used with in-line ventilator in home care environment. |
| 2022-04-26 |
Class I
|
Terminated |
Z-1138-2022 |
In-Line ventilator adaptor |
— |
There is a potential of reduced oxygenation or pneumothorax/barotrauma to occur when the Volara system is used with in-line ventilator in home care environment. |
| 2022-04-21 |
Class II
|
Completed |
Z-1146-2022 |
APD Drain Manifold |
— |
Certain Peritoneal Dialysis product codes do not have FDA regulatory clearance and were distributed within the United States in error. |
| 2022-04-21 |
Class II
|
Completed |
Z-1145-2022 |
3,65 m Extension Set with Luer-lock Connector |
— |
Certain Peritoneal Dialysis product codes do not have FDA regulatory clearance and were distributed within the United States in error. |
| 2022-04-21 |
Class II
|
Completed |
Z-1144-2022 |
Effluent Sample Bag |
— |
Certain Peritoneal Dialysis product codes do not have FDA regulatory clearance and were distributed within the United States in error. |
| 2022-04-21 |
Class II
|
Completed |
Z-1143-2022 |
5 Prong Manifold Set (with Luer Connectors) |
— |
Certain Peritoneal Dialysis product codes do not have FDA regulatory clearance and were distributed within the United States in error. |
| 2022-04-21 |
Class II
|
Completed |
Z-1142-2022 |
Locking Cap for PD Catheter Adapter |
— |
Certain Peritoneal Dialysis product codes do not have FDA regulatory clearance and were distributed within the United States in error. |
| 2022-04-21 |
Class II
|
Completed |
Z-1141-2022 |
15 Liters Drain Bag |
— |
Certain Peritoneal Dialysis product codes do not have FDA regulatory clearance and were distributed within the United States in error. |
| 2022-04-13 |
Class II
|
Terminated |
Z-1094-2022 |
Voalte Nurse Call System provides a comprehensive communication and information system that places patient calls, sta… |
— |
Firm discovered a firmware memory leak with a supplier-manufactured component. |
| 2022-04-13 |
Class II
|
Terminated |
Z-1093-2022 |
NaviCare Nurse Call System provides a comprehensive communication and information system that places patient calls, s… |
— |
Firm discovered a firmware memory leak with a supplier-manufactured component. |
| 2022-04-01 |
Class II
|
Ongoing |
Z-1019-2022 |
Flo-Thru Intraluminal Shunt. Used in coronary artery or peripheral vascular procedures. Used to shunt blood at the anast… |
— |
There is a potential for foreign matter. |
| 2022-03-15 |
Class II
|
Ongoing |
Z-0993-2022 |
PrisMax System, Product Codes: a) 955558, b) 955627, c) 955701 |
— |
This correction is due to software anomalies occurring during use. If the operator initiates therapy by entering a value other than the default value for the pa… |
| 2022-03-15 |
Class II
|
Ongoing |
Z-0992-2022 |
PrisMax System, Product Code 955724 |
— |
This correction is due to software anomalies occurring during use. If the operator initiates therapy by entering a value other than the default value for the pa… |
| 2022-03-15 |
Class II
|
Ongoing |
Z-0991-2022 |
PrisMax System, Product Code 955626 |
— |
This correction is due to software anomalies occurring during use. If the operator initiates therapy by entering a value other than the default value for the pa… |
| 2022-02-25 |
Class II
|
Terminated |
Z-0948-2022 |
Baxter DISCPAC Syringe Tip Caps, Self-Righting, Luer Slip, Yellow, REF H93866100, 100 slip tip caps/package. |
— |
Product is mislabeled as self-righting Luer slip tip caps, yellow. |
| 2022-02-25 |
Class II
|
Terminated |
Z-0831-2022 |
MiniCap Extended Life PD Transfer Set Product Codes: 5C4482S, R5C4482, R5C4483, R5C4484 |
— |
Devices distributed lacked regulatory clearance. |
| 2022-02-21 |
Class II
|
Ongoing |
Z-0829-2022 |
Liko Universal Twinbar 670 QRH, an accessory that can be used together with most Liko lifts, model numbers 3156087 and P… |
— |
An incorrect center bolt was used in the assembly of the product which could result in a patient fall during use. |
| 2022-02-14 |
Class II
|
Ongoing |
Z-0821-2022 |
Compella Therapy Air Supply Unit |
— |
Potential damage to the power cord may cause the power conductors to be exposed, thereby creating a risk of shock from the power mains. |
| 2022-02-14 |
Class II
|
Ongoing |
Z-0820-2022 |
Compella Bariatric Bed System |
— |
Potential damage to the power cord may cause the power conductors to be exposed, thereby creating a risk of shock from the power mains. |
| 2022-01-07 |
Class II
|
Ongoing |
Z-0580-2022 |
Baxter CAPD System Transfer Set (CAPD MiniCap Transfer Set II (34cm)), Code No. T5C4484 |
— |
Cleaning products, containing, but not limited to, hydrogen peroxide, bleach, alcohol, or antiseptic agents and solvent, such as those containing acetone, tolue… |
| 2022-01-07 |
Class II
|
Ongoing |
Z-0579-2022 |
Baxter CAPD System Transfer Set (CAPD MiniCap Transfer Set II (24cm)), Code No. T5C4482 |
— |
Cleaning products, containing, but not limited to, hydrogen peroxide, bleach, alcohol, or antiseptic agents and solvent, such as those containing acetone, tolue… |
| 2022-01-07 |
Class II
|
Ongoing |
Z-0578-2022 |
Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp - Extra Long, REF R5C4484 |
— |
Cleaning products, containing, but not limited to, hydrogen peroxide, bleach, alcohol, or antiseptic agents and solvent, such as those containing acetone, tolue… |
| 2022-01-07 |
Class II
|
Ongoing |
Z-0577-2022 |
Baxter MiniCap Extended Life PD Transfer Set Twist Clamp - Extra Short, REF R5C4483 |
— |
Cleaning products, containing, but not limited to, hydrogen peroxide, bleach, alcohol, or antiseptic agents and solvent, such as those containing acetone, tolue… |
| 2022-01-07 |
Class II
|
Ongoing |
Z-0576-2022 |
Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, REF R5C4482E |
— |
Cleaning products, containing, but not limited to, hydrogen peroxide, bleach, alcohol, or antiseptic agents and solvent, such as those containing acetone, tolue… |
| 2022-01-07 |
Class II
|
Ongoing |
Z-0575-2022 |
Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, REF R5C4482 |
— |
Cleaning products, containing, but not limited to, hydrogen peroxide, bleach, alcohol, or antiseptic agents and solvent, such as those containing acetone, tolue… |
| 2022-01-07 |
Class II
|
Ongoing |
Z-0574-2022 |
Baxter Equipo de transferencia para DP MiniCap de vida util prolongada con pinza de torsion, 5C4482S |
— |
Cleaning products, containing, but not limited to, hydrogen peroxide, bleach, alcohol, or antiseptic agents and solvent, such as those containing acetone, tolue… |
| 2022-01-07 |
Class II
|
Ongoing |
Z-0573-2022 |
Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, 5C4482EJ |
— |
Cleaning products, containing, but not limited to, hydrogen peroxide, bleach, alcohol, or antiseptic agents and solvent, such as those containing acetone, tolue… |
| 2022-01-07 |
Class II
|
Ongoing |
Z-0572-2022 |
Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp - Extra Short, 5C4483 |
— |
Cleaning products, containing, but not limited to, hydrogen peroxide, bleach, alcohol, or antiseptic agents and solvent, such as those containing acetone, tolue… |
| 2022-01-07 |
Class II
|
Ongoing |
Z-0571-2022 |
Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, 5C4482 |
— |
Cleaning products, containing, but not limited to, hydrogen peroxide, bleach, alcohol, or antiseptic agents and solvent, such as those containing acetone, tolue… |
| 2022-01-07 |
Class II
|
Ongoing |
Z-0570-2022 |
Baxter MiniCap Extended Life PD Transfer Set (Easy-Lock), 5C4449 |
— |
Cleaning products, containing, but not limited to, hydrogen peroxide, bleach, alcohol, or antiseptic agents and solvent, such as those containing acetone, tolue… |
| 2021-12-29 |
Class I
|
Ongoing |
Z-0530-2022 |
Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 8), Product code 35700BAX2. |
— |
There is the potential for reduced or non-delivery of medication, in some cases without alerting the user via pump alarm. This may occur as a result of incorrec… |
| 2021-12-29 |
Class I
|
Ongoing |
Z-0529-2022 |
Baxter Spectrum IQ Infusion Pumps, Product code 3570009. |
— |
There is the potential for reduced or non-delivery of medication, in some cases without alerting the user via pump alarm. This may occur as a result of incorrec… |
| 2021-09-29 |
Class II
|
Ongoing |
Z-0215-2022 |
Hemodialysis Delivery System, Software Version 2.x. |
— |
If the operator initiates therapy with a saved prescription profile and makes a change to the prescription after a disposable filter change using the Same Pati… |
| 2021-07-22 |
Class II
|
Terminated |
Z-2379-2021 |
Baxter prismaflex, HF 1000 PAES membrane, REF 107140 Used with Prismaflex or PrisMax control units for continuous fl… |
— |
Products labeled as sterile were distributed, but may not have been sterilized. Baxter confirmed Steril Milano observed nonconformances that were not reported … |
| 2021-07-22 |
Class II
|
Terminated |
Z-2378-2021 |
Baxter PrismaFlex, REF numbers: a) 106696 (M 60 SET) b) 106697 (M 100 SET) Expansion: c) 107144 (TPE2000 SET) d… |
— |
Products labeled as sterile were distributed, but may not have been sterilized. " Baxter confirmed Steril Milano observed nonconformances that were not reporte… |
| 2021-07-07 |
Class I
|
Terminated |
Z-2165-2021 |
Dose IQ Safety Software used with Spectrum IQ Infusion Pump |
— |
Software issue: The defect creates a mismatch between linked drug identifiers (IDs) in the Dose IQ user interface (UI) and the binary drug library (BDL) loaded… |
| 2021-06-30 |
Class II
|
Terminated |
Z-2174-2021 |
Kaguya Automated Peritoneal Dialysis System |
— |
Baxter Healthcare Corporation has identified that the AMIA Sharesource User Guide that is used with the AMIA Automated PD System cyclers incorrectly describes t… |
| 2021-06-30 |
Class II
|
Terminated |
Z-2173-2021 |
Sharesource Connectivity Platform for Use with the Amia Automated PD System |
— |
Baxter Healthcare Corporation has identified that the AMIA Sharesource User Guide that is used with the AMIA Automated PD System cyclers incorrectly describes t… |
| 2021-06-15 |
Class II
|
Terminated |
Z-2051-2021 |
EASYGRIP FLO-41 US. For delivering hemostatic agents to bleeding sites through a trocar. |
— |
There is a discrepancy in the expiry date encoded into the 2D barcode. The correct expiration date is the human-readable date |
| 2021-06-04 |
Class I
|
Terminated |
Z-2110-2021 |
Spectrum IQ Infusion System with Dose IQ Safety Software, Product Code 3570009. for the controlled administration of fl… |
— |
System errors were noted following changes the customers implemented to the configuration of their network and server systems. Gateway Server System performance… |
| 2021-04-14 |
Class II
|
Terminated |
Z-1684-2021 |
Gambro Cartridge Blood Set, Product Code 101025 - Product Usage: intended for single use in a hemodialysis treatment usi… |
— |
There is a potential leak between the venous patient connector and patient's hemodialysis access. |
| 2021-03-19 |
Class II
|
Terminated |
Z-1487-2021 |
Spectrum IQ - Infusion Pump - Product Usage: intended to be used for the controlled administration of fluids. |
— |
Potentially defective component in the AC power adapter which may fail over time. |
| 2021-01-28 |
Class II
|
Terminated |
Z-1280-2021 |
Preventative Maintenance Kits G5010007) and spare part kits (G5064801 and G5006203) - Product Usage: For Prismaflex Cont… |
— |
Variability in the performance of the tubing in the Prismaflex Control Unit ARPS (Automatic Repositioning System) Pump Assembly, may lead to alarm situations du… |
| 2021-01-28 |
Class II
|
Terminated |
Z-1279-2021 |
Prismaflex Control Unit - Product Usage: Used for Continuous Renal Replacement Therapy (CRRT). |
— |
Variability in the performance of the tubing in the Prismaflex Control Unit ARPS (Automatic Repositioning System) Pump Assembly, may lead to alarm situations du… |
| 2021-01-28 |
Class II
|
Terminated |
Z-1278-2021 |
Prismaflex Control Unit - Product Usage: Used for Continuous Renal Replacement Therapy (CRRT). |
— |
Variability in the performance of the tubing in the Prismaflex Control Unit ARPS (Automatic Repositioning System) Pump Assembly, may lead to alarm situations du… |
| 2021-01-28 |
Class II
|
Terminated |
Z-1277-2021 |
Prismaflex Control Unit - Product Usage: Used for Continuous Renal Replacement Therapy (CRRT). |
— |
Variability in the performance of the tubing in the Prismaflex Control Unit ARPS (Automatic Repositioning System) Pump Assembly, may lead to alarm situations du… |
| 2021-01-07 |
Class II
|
Terminated |
Z-1151-2021 |
The PrisMax System Version II Hemodialysis Delivery System: Automatic Repositioning System Pump Assembly, specifically t… |
— |
Variability in the performance of the tubing in the ARPS (Automatic Repositioning System) Pump Assembly which may lead to alarm situations during system self-te… |
| 2021-01-06 |
Class II
|
Terminated |
Z-1150-2021 |
Infusion Pump |
— |
Battery performance issues related to prolonged storage. |
| 2020-12-30 |
Class II
|
Ongoing |
Z-1123-2021 |
Gambro Cartridge Low Weight-Low Volume Blood Transport System for Hemodialysis Blood Set, product code 114435 - Product … |
— |
complaints of kinked access lines observed during treatment using cartridge sets for hemodialysis treatments were received. |
| 2020-12-30 |
Class II
|
Ongoing |
Z-1122-2021 |
Gambro Cartridge Low Volume Blood Transport System for Hemodialysis Blood Set, product code 114434 - Product Usage: inte… |
— |
complaints of kinked access lines observed during treatment using cartridge sets for hemodialysis treatments were received. |
| 2020-12-30 |
Class II
|
Ongoing |
Z-1121-2021 |
Gambro Cartridge Blood Transport System for Hemodialysis Blood Set, product code 109536 - Product Usage: intended for si… |
— |
complaints of kinked access lines observed during treatment using cartridge sets for hemodialysis treatments were received. |
| 2020-12-30 |
Class II
|
Ongoing |
Z-1120-2021 |
Gambro Cartridge Blood Transport System for Hemodialysis Blood Set, product code 106289 - Product Usage: intended for si… |
— |
complaints of kinked access lines observed during treatment using cartridge sets for hemodialysis treatments were received. |
| 2020-12-30 |
Class II
|
Ongoing |
Z-1119-2021 |
Gambro Cartridge Single Needle Conversion Kit, product code 101290 - Product Usage: intended for single use in a hemodia… |
— |
complaints of kinked access lines observed during treatment using cartridge sets for hemodialysis treatments were received. |
| 2020-12-30 |
Class II
|
Ongoing |
Z-1118-2021 |
Gambro Cartridge Blood Set Prime Line, product code 101025 - Product Usage: intended for single use in a hemodialysis tr… |
— |
complaints of kinked access lines observed during treatment using cartridge sets for hemodialysis treatments were received. |
| 2020-12-28 |
Class II
|
Ongoing |
Z-0939-2021 |
FLOW COUPLER Monitor Flow Coupler devices are sold in 5 sizes (2.0 mm, 2.5 mm, 3.0 mm, 3.5 mm, 4.0 mm). Implantable d… |
— |
Potential for the battery to lose its ability to be recharged. |
| 2020-12-21 |
Class II
|
Terminated |
Z-1102-2021 |
Baxter ONE-LINK Non-DEHP Y-Type Microbore Catheter Extension Set, Bonded Needle-free IV Connector, Neutral Fluid Displac… |
— |
There were customer reports of separation between the tubing and Male Luer Lock Adaptor. |
| 2020-12-11 |
Class II
|
Terminated |
Z-0807-2021 |
VERITAS Collagen Matrix - Product Usage: intended for use in reconstruction of the pelvic floor excluding transvaginal p… |
— |
VERITAS Collagen Matrix 12x25 cm Patches may have undersized width dimensions. |
| 2020-11-23 |
Class II
|
Ongoing |
Z-0715-2021 |
Baxter Spectrum IQ Infusion System with Dose IQ Safety Software - Product Usage: intended to be used for the controlled … |
— |
There is a potential software error during programming. |
| 2020-11-23 |
Class II
|
Ongoing |
Z-0714-2021 |
Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 8) - Product Usage: intended to be used for the co… |
— |
There is a potential software error during programming. |
| 2020-11-23 |
Class II
|
Ongoing |
Z-0713-2021 |
Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 6) - Product Usage: intended to be used for the co… |
— |
There is a potential software error during programming. |
| 2020-11-23 |
Class II
|
Ongoing |
Z-0712-2021 |
Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 6) - Product Usage: intended to be used for the co… |
— |
There is a potential software error during programming. |
| 2020-11-10 |
Class II
|
Terminated |
Z-0768-2021 |
MiniCap Extended Life PD Transfer Set |
— |
Potential for no-flow and leaks under the twist clamp. |
| 2020-06-30 |
Class I
|
Terminated |
Z-0123-2021 |
Spectrum IQ Infusion System with Dose IQ Safety Software |
— |
Baxter is updating the device IFU for safety communication regarding cleaning practices. |
| 2020-06-30 |
Class I
|
Terminated |
Z-0122-2021 |
Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 8) |
— |
Baxter is updating the device IFU for safety communication regarding cleaning practices. |
| 2020-06-30 |
Class I
|
Terminated |
Z-0121-2021 |
Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 8) |
— |
Baxter is updating the device IFU for safety communication regarding cleaning practices. |
| 2020-06-30 |
Class I
|
Terminated |
Z-0120-2021 |
Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 6) |
— |
Baxter is updating the device IFU for safety communication regarding cleaning practices. |
| 2020-06-02 |
Class II
|
Ongoing |
Z-2474-2020 |
Flow Coupler Monitor, GEM, Global Excellence Microsurgery, Rx Only |
— |
A firmware issue may cause the GEM1020M-2 Flow Coupler Monitor to intermittently shut down when a WiFi connection is not established. |
| 2020-04-17 |
Class II
|
Terminated |
Z-2196-2020 |
Gambro Cartridge Low Weight-Low Volume Blood Transport System for Hemodialysis Blood Set - Product Usage: is intended fo… |
— |
Potential disconnection of tubing set. |
| 2020-04-17 |
Class II
|
Terminated |
Z-2195-2020 |
Gambro Cartridge Low Volume Blood Transport System for Hemodialysis Blood Set - Product Usage: is intended for single us… |
— |
Potential disconnection of tubing set. |
| 2020-04-17 |
Class II
|
Terminated |
Z-2194-2020 |
Gambro Cartridge Blood Transport System for Hemodialysis Blood Set - Product Usage: is intended for single use in a hemo… |
— |
Potential disconnection of tubing set. |
| 2020-04-17 |
Class II
|
Terminated |
Z-2193-2020 |
Gambro Cartridge Blood Set Prime Line - Product Usage: is intended for single use in a hemodialysis treatment using Dial… |
— |
Potential disconnection of tubing set. |
| 2020-04-07 |
Class II
|
Terminated |
Z-2066-2020 |
Prismaflex Control Unit |
— |
Prismaflex product code 114870 does not have FDA regulatory clearance and was inadvertently distributed. |
| 2020-03-05 |
Class II
|
Terminated |
Z-1687-2020 |
GEM Microvascular Anastomotic Coupler Devices s intended to be used in the anastomosis of veins and arteries normally en… |
— |
The Coupler size labeling of the outer tray may not match the Couper size labeling of the inner tray in the GEM Microvascular Coupler Device |
| 2020-03-05 |
Class II
|
Terminated |
Z-1686-2020 |
GEM Microvascular Anastomotic Coupler Devices - Product Usage: s intended to be used in the anastomosis of veins and art… |
— |
The Coupler size labeling of the outer tray may not match the Couper size labeling of the inner tray in the GEM Microvascular Coupler Device |
| 2020-03-05 |
Class II
|
Terminated |
Z-1685-2020 |
GEM Microvascular Anastomotic Coupler Devices - Product Usage: is intended to be used in the anastomosis of veins and ar… |
— |
The Coupler size labeling of the outer tray may not match the Couper size labeling of the inner tray in the GEM Microvascular Coupler Device |
| 2020-02-06 |
Class II
|
Terminated |
Z-1833-2020 |
Prismaflex System, Prismaflex Control Unit |
— |
Baxter is communicating safety information from the Prismaflex Operator's Manual regarding the proper use of connectors with the Prismaflex system. |
| 2020-02-06 |
Class II
|
Terminated |
Z-1832-2020 |
Prismaflex System, Prismaflex Control Unit |
— |
Baxter is communicating safety information from the Prismaflex Operator's Manual regarding the proper use of connectors with the Prismaflex system. |
| 2020-02-06 |
Class II
|
Terminated |
Z-1831-2020 |
Prismaflex System, Prismaflex Control Unit |
— |
Baxter is communicating safety information from the Prismaflex Operator's Manual regarding the proper use of connectors with the Prismaflex system. |
| 2020-02-06 |
Class II
|
Terminated |
Z-1830-2020 |
Prismaflex System, Prismaflex Control Unit |
— |
Baxter is communicating safety information from the Prismaflex Operator's Manual regarding the proper use of connectors with the Prismaflex system. |
| 2020-02-06 |
Class II
|
Terminated |
Z-1829-2020 |
Prismaflex System, Prismaflex Control Unit |
— |
Baxter is communicating safety information from the Prismaflex Operator's Manual regarding the proper use of connectors with the Prismaflex system. |
| 2020-02-06 |
Class II
|
Terminated |
Z-1828-2020 |
Prismaflex System, Prismaflex Control Unit |
— |
Baxter is communicating safety information from the Prismaflex Operator's Manual regarding the proper use of connectors with the Prismaflex system. |