| 2026-01-30 |
Class II
|
Ongoing |
Z-1557-2026 |
HealthCast "Vital Sync" Remote Patient Monitoring System which consists of: Product Number: VSLBASE03P / VITALSYNCSW03… |
— |
Due to complaints and investigations stating that alarms from the primary patient bedside monitor was not alarming/being transmitted and received on the remote … |
| 2025-06-23 |
Class II
|
Ongoing |
Z-2151-2025 |
Covidien Nellcor Bedside SpO2 Patient Monitoring System: REF: PM100N, 10005941, DLPM100N, DL10005941, DSPM100N, 10005941… |
— |
Bedside SpO2 Patient Monitoring System alarms not heard/recognized, resulting in: treatment delay, lack of low oxygen saturation response, respiratory failure, … |
| 2025-05-21 |
Class I
|
Ongoing |
Z-1915-2025 |
Newport HT70 Ventilator, REF: HT70M-JP-NA, HT70M-CN-NA, HT70M-ES-EU, HT70M-PT-BR, HT70M-SY-EU, HT70M-WW-EU, HT70M-WW-NA,… |
— |
Ventilator Printed Circuit Board Assembly may have two separate capacitors that may fail, which may result in the ventilator either shutting down during use, th… |
| 2025-02-26 |
Class I
|
Ongoing |
Z-1390-2025 |
Shiley Adult Flexible Tracheostomy Tube with TaperGuard Cuff Reusable Inner Cannula, REF: 7CN80R |
— |
Tracheostomy tube with cuff reusable inner cannula has a flange that may disconnect from the outer cannula of the device, which could cause respiratory failure,… |
| 2024-07-09 |
Class II
|
Ongoing |
Z-2717-2024 |
Covideien McGRATH MAC Video Laryngoscope, REF: 301-000-000, Non-Sterile, RxOnly |
— |
IFU update to address device's battery handling information. |
| 2024-07-09 |
Class I
|
Ongoing |
Z-2637-2024 |
McGRATH" MAC EMS Video Laryngoscope, REF: 300-200-000 , Non-Sterile, Rx Only |
— |
Battery management system within Laryngoscope devices may deplete below the deign threshold which may result in thermal event followed by risk of explosion. |
| 2024-07-09 |
Class I
|
Ongoing |
Z-2636-2024 |
McGrath Mac Video Laryngoscope, REF: 300-000-000 , Non-Sterile, Rx Only |
— |
Battery management system within Laryngoscope devices may deplete below the deign threshold which may result in thermal event followed by risk of explosion. |
| 2024-06-24 |
Class I
|
Ongoing |
Z-2446-2024 |
Puritan Bennett 500 Series Ventilators (Description/REF): PURITAN BENNETT 560 VENTILATOR/4096600, PURITAN BENNETT PB56… |
— |
Any single affected ventilator should only be used for the 10- year labelled service life, but if longer ventilatory support is required using more than one ven… |
| 2024-04-25 |
Class II
|
Ongoing |
Z-2038-2024 |
EsoFLIP, 30mm BALLOON DILATION CATHETER, REF ES-330, Rx Only |
— |
Due to saline conductivity issues, their is a potential that dilation catheters may provide inaccurate esophageal diameter measurements that may lead to variou… |
| 2024-02-21 |
Class II
|
Ongoing |
Z-1330-2024 |
Situate Laparotomy Sponge, RF and X-ray Detectable, REF: L1818-04P01C-1 |
— |
Packs including 5 laparotomy sponges may contain incorrect product with a blue loop, X-ray detectable feature, and ethylene oxide treatment; however, this inco… |
| 2024-01-09 |
Class II
|
Ongoing |
Z-1732-2024 |
Medtronic Invos, Reusable Sensor Cable for PM7100, REF: PMAC71RSC |
— |
manufacturing defects to sensor cable connectors may result in error codes or non-functioning channel |
| 2024-01-09 |
Class II
|
Ongoing |
Z-1731-2024 |
Medtronic Invos, Reusable Infant Sensor Adapter Cable for PM7100, REF: PMAC71RIC |
— |
manufacturing defects to sensor cable connectors may result in error codes or non-functioning channel |
| 2023-11-16 |
Class II
|
Ongoing |
Z-0631-2024 |
Covidien Valleylab FT10, FT Series Energy Platform, REF: VLFT10GEN, DLVLFT10GEN, VLFT10GENZD |
— |
Due to software issue, New systems may exhibit an error which may prohibit use of new systems resulting in system being inoperable |
| 2023-09-28 |
Class I
|
Ongoing |
Z-0144-2024 |
Stolen McGRATH MAC Video Laryngoscopes, REF: 301-000-000 |
— |
Defective video laryngoscopes that did not pass quality tests established for the product, that were designated for destruction, were stolen, and subsequently d… |
| 2023-08-22 |
Class II
|
Ongoing |
Z-2651-2023 |
Puritan Bennett Cuff Pressure Manager, REF: 180-03 |
— |
Inadequate internal fixation of the power inlet port to the cuff pressure manager device causes the external power inlet to became dislodged within the device h… |
| 2023-08-10 |
Class II
|
Ongoing |
Z-0169-2024 |
McGrath Mac 2, Disposable Laryngoscope Blade, REF: 350-084-000, Sterile EO, Rx Only |
— |
Laryngoscope blades may contain an ineffective application of anti-fog agent which may result in condensation accumulating causing the screen to be blurred or o… |
| 2023-08-10 |
Class II
|
Ongoing |
Z-0168-2024 |
McGrath Mac 2, Disposable Laryngoscope Blade, REF: 350-017-000, Sterile EO, Rx Only |
— |
Laryngoscope blades may contain an ineffective application of anti-fog agent which may result in condensation accumulating causing the screen to be blurred or o… |
| 2023-06-02 |
Class II
|
Ongoing |
Z-2282-2023 |
Covidien Cytosponge Cell Collection Device, REF: CYTO-201; and Covidien Cytosponge Cell Collection Kit, REF: CYTO-KIT-US… |
— |
Cell Collection Device may be at increased risk of the sponge detaching from the string during removal of the device from the patient, which could lead to devic… |
| 2023-05-22 |
Class II
|
Ongoing |
Z-2008-2023 |
Medtronic ILLUMISITE Platform Console, Model Number ILS-1000-CS |
— |
Single ILLUMISITE Platform Console was converted from a 220-240VAC model to a 120VAC configuration using a non-supplied power cord and non-supplied fuses in the… |
| 2023-03-24 |
Class I
|
Ongoing |
Z-1357-2023 |
Shiley Adult Flexible Tracheostomy Tube with TaperGuard Cuff, and Cuffless: Disposable Inner Cannula or Reusable Inner … |
— |
A manufacturing error, resulted in a less than specified diameter of adult flexible tracheostomy tube connectors, which results in unsecure connections with 15m… |
| 2023-02-10 |
Class II
|
Ongoing |
Z-1318-2023 |
COVIDIEN Shiley Lo-Pro Oral/Nasal Tracheal Tube Cuffed REF 86051 7.0 mm I.D. The Shiley Lo-Pro Oral/Nasal Tracheal Tu… |
— |
Due to potential leaks associate with the Oral/Nasal Tracheal Tube Cuffed inflation system. |
| 2022-11-23 |
Class II
|
Ongoing |
Z-0955-2023 |
COVIDIEN Emprint Ablation Catheter with Thermosphere Technology, Bronchoscopic Ablation, REF CA108L1 |
— |
The product is labeled with the incorrect expiration date. |
| 2022-08-19 |
Class II
|
Ongoing |
Z-1775-2022 |
Puritan Bennett 560 Ventilator, PB560, CFN 4096600 |
— |
Medtronic has confirmed six reports from customers outside the US where the ventilator became inoperable due to loss of gas supply caused by manufacturing error… |
| 2022-06-08 |
Class I
|
Ongoing |
Z-1320-2022 |
Mahurkar Chronic Carbothane (Maxid) Catheter, Sterile, Single Use, Rx Only. For acute and chronic hemodialysis, apheresi… |
— |
There is a potential leaking condition within the hub of specific chronic dialysis catheters, due to an inter-lumen void in the hub component, which may result … |
| 2022-06-08 |
Class I
|
Ongoing |
Z-1319-2022 |
Palindrome HSI Chronic Catheter, Sterile, Single Use, Rx Only. For acute and chronic hemodialysis, apheresis, and infusi… |
— |
There is a potential leaking condition within the hub of specific chronic dialysis catheters, due to an inter-lumen void in the hub component, which may result … |
| 2022-06-08 |
Class I
|
Ongoing |
Z-1318-2022 |
Palindrome SI Chronic Catheter, Sterile, Single Use, Rx Only. For acute and chronic hemodialysis, apheresis, and infusio… |
— |
There is a potential leaking condition within the hub of specific chronic dialysis catheters, due to an inter-lumen void in the hub component, which may result … |
| 2022-06-08 |
Class I
|
Ongoing |
Z-1317-2022 |
Palindrome H Chronic Catheter, Sterile, Single Use, Rx Only. For acute and chronic hemodialysis, apheresis, and infusion… |
— |
There is a potential leaking condition within the hub of specific chronic dialysis catheters, due to an inter-lumen void in the hub component, which may result … |
| 2022-06-08 |
Class I
|
Ongoing |
Z-1316-2022 |
Palindrome Chronic Catheter, Sterile, Single Use, Rx Only. For vascular access for acute and chronic hemodialysis, apher… |
— |
There is a potential leaking condition within the hub of specific chronic dialysis catheters, due to an inter-lumen void in the hub component, which may result … |
| 2022-06-08 |
Class I
|
Ongoing |
Z-1315-2022 |
Palindrome Precision HSI Chronic Catheter, Sterile, Single Use, Rx Only. For acute and chronic hemodialysis, apheresis, … |
— |
There is a potential leaking condition within the hub of specific chronic dialysis catheters, due to an inter-lumen void in the hub component, which may result … |
| 2022-06-08 |
Class I
|
Ongoing |
Z-1314-2022 |
Palindrome Precision SI Chronic Catheter, Sterile, Single Use, Rx Only. For vascular access for acute and chronic hemodi… |
— |
There is a potential leaking condition within the hub of specific chronic dialysis catheters, due to an inter-lumen void in the hub component, which may result … |
| 2022-06-08 |
Class I
|
Ongoing |
Z-1313-2022 |
Palindrome Precision H Chronic Catheter, Sterile, Single Use, Rx Only. For vascular access for acute and chronic hemodia… |
— |
There is a potential leaking condition within the hub of specific chronic dialysis catheters, due to an inter-lumen void in the hub component, which may result … |
| 2022-06-08 |
Class I
|
Ongoing |
Z-1312-2022 |
Palindrome Precision Chronic Catheter, Sterile, Single Use, Rx Only. For vascular access for acute and chronic hemodialy… |
— |
There is a potential leaking condition within the hub of specific chronic dialysis catheters, due to an inter-lumen void in the hub component, which may result … |
| 2022-06-07 |
Class II
|
Ongoing |
Z-1467-2022 |
TruClear Hysteroscopic Tissue Removal System Control Unit- designed to meet the requirements of intrauterine tissue remo… |
— |
Electrical component failure within the control unit. The observed failure mode is a loss of function of the device when used with handpiece and foot switch. |
| 2021-12-17 |
Class II
|
Ongoing |
Z-0557-2022 |
Chameleon PTA Balloon Dilation Catheter 8 mm x 40 mm, Chameleon PTA Balloon Catheter with Injection Port 8 mm x 40 mm; C… |
— |
The firm has received six (6) complaint reports from customers indicating difficulty removing the balloon protector sleeve from the catheter (e.g., excessive fo… |
| 2021-12-06 |
Class II
|
Terminated |
Z-0495-2022 |
LigaSure Blunt Tip Laparoscopic Sealer/Divider, Nano-Coated, Product Number LF1837 |
— |
Customers reported that the device jaws were difficult to open or would not open following application on tissue. Use of a device with this potential assembly … |
| 2021-11-12 |
Class II
|
Ongoing |
Z-0332-2022 |
Covidien Sonicision Battery Charger-intended to charge the Sonicision Reusable Battery Pack and to provide information o… |
— |
Intermittent risk of electric shock to users if an affected charger is used in conjunction with a faulty or bypassed institutions Mains Protective Earth (Ground… |
| 2021-11-04 |
Class I
|
Terminated |
Z-0353-2022 |
Puritan Bennett 980 Series Ventilator, 980X3JADIJJ |
— |
Manufacturing assembly error where a capacitor within the ventilator was assembled incorrectly, which may cause the device to become inoperable during use. |
| 2021-11-04 |
Class I
|
Terminated |
Z-0352-2022 |
Puritan Bennett 980 Series Ventilator, 980X3ENDIUU |
— |
Manufacturing assembly error where a capacitor within the ventilator was assembled incorrectly, which may cause the device to become inoperable during use. |
| 2021-11-04 |
Class I
|
Terminated |
Z-0351-2022 |
Puritan Bennett 980 Series Ventilator, 980X2ESDIEC |
— |
Manufacturing assembly error where a capacitor within the ventilator was assembled incorrectly, which may cause the device to become inoperable during use. |
| 2021-11-04 |
Class I
|
Terminated |
Z-0350-2022 |
Puritan Bennett 980 Series Ventilator, 980X1PLDIPC |
— |
Manufacturing assembly error where a capacitor within the ventilator was assembled incorrectly, which may cause the device to become inoperable during use. |
| 2021-11-04 |
Class I
|
Terminated |
Z-0349-2022 |
Puritan Bennett 980 Series Ventilator, 980X1JADIJJ |
— |
Manufacturing assembly error where a capacitor within the ventilator was assembled incorrectly, which may cause the device to become inoperable during use. |
| 2021-11-04 |
Class I
|
Terminated |
Z-0348-2022 |
Puritan Bennett 980 Series Ventilator, 980X1ENNISB |
— |
Manufacturing assembly error where a capacitor within the ventilator was assembled incorrectly, which may cause the device to become inoperable during use. |
| 2021-11-04 |
Class I
|
Terminated |
Z-0347-2022 |
Puritan Bennett 980 Series Ventilator, 980X1ENDIUU |
— |
Manufacturing assembly error where a capacitor within the ventilator was assembled incorrectly, which may cause the device to become inoperable during use. |
| 2021-11-04 |
Class I
|
Terminated |
Z-0346-2022 |
Puritan Bennett 980 Series Ventilator, 980X1ENDIPC |
— |
Manufacturing assembly error where a capacitor within the ventilator was assembled incorrectly, which may cause the device to become inoperable during use. |
| 2021-11-04 |
Class I
|
Terminated |
Z-0345-2022 |
Puritan Bennett 980 Series Ventilator,980X1ENAIQC |
— |
Manufacturing assembly error where a capacitor within the ventilator was assembled incorrectly, which may cause the device to become inoperable during use. |
| 2021-11-04 |
Class I
|
Terminated |
Z-0344-2022 |
Puritan Bennett 980 Series Ventilator, 980U3ESDIUU |
— |
Manufacturing assembly error where a capacitor within the ventilator was assembled incorrectly, which may cause the device to become inoperable during use. |
| 2021-11-04 |
Class I
|
Terminated |
Z-0343-2022 |
Puritan Bennett 980 Series Ventilator, 980U1ESDIUC |
— |
Manufacturing assembly error where a capacitor within the ventilator was assembled incorrectly, which may cause the device to become inoperable during use. |
| 2021-11-04 |
Class I
|
Terminated |
Z-0342-2022 |
Puritan Bennett 980 Series Ventilator, 980U1ENASAA |
— |
Manufacturing assembly error where a capacitor within the ventilator was assembled incorrectly, which may cause the device to become inoperable during use. |
| 2021-11-04 |
Class I
|
Terminated |
Z-0341-2022 |
Puritan Bennett 980 Series Ventilator, 980S3ENDICU |
— |
Manufacturing assembly error where a capacitor within the ventilator was assembled incorrectly, which may cause the device to become inoperable during use. |
| 2021-11-04 |
Class I
|
Terminated |
Z-0340-2022 |
Puritan Bennett 980 Series Ventilator, 980S1ENDICU |
— |
Manufacturing assembly error where a capacitor within the ventilator was assembled incorrectly, which may cause the device to become inoperable during use. |
| 2021-11-04 |
Class I
|
Terminated |
Z-0339-2022 |
Puritan Bennett 980 Series Ventilator, 980A3ENNISB |
— |
Manufacturing assembly error where a capacitor within the ventilator was assembled incorrectly, which may cause the device to become inoperable during use. |
| 2021-11-04 |
Class I
|
Terminated |
Z-0338-2022 |
Puritan Bennett 980 Series Ventilator, 980A1ENNISB |
— |
Manufacturing assembly error where a capacitor within the ventilator was assembled incorrectly, which may cause the device to become inoperable during use. |
| 2021-09-29 |
Class II
|
Terminated |
Z-0210-2022 |
Covidien Emprint Ablation Catheter with Thermosphere Technology Bronchoscopic Ablation, CFN CA108L1 |
— |
The firm identified an error in the device temperature monitoring circuitry which is designed to interrupt energy delivery in the event of a primary cooling sys… |
| 2021-06-23 |
Class II
|
Terminated |
Z-2240-2021 |
Covidien Sonicision Reusable Generator-converts electrical power from the battery pack to ultrasonic energy to drive the… |
— |
Potential for a manufacturing assembly error-may result in a non-functional audio indicator of device activation or a non-functional device, may cause unintende… |
| 2021-03-23 |
Class II
|
Terminated |
Z-1419-2021 |
Covidien Tri-Staple 2.0 Reinforced Intelligent Reload 60 mm Medium/Thick-For use with Signia stapling system. Staple lin… |
— |
Potential for the pouch to contain an extra laminate layer, creating the potential for the device sterility to be compromised. The inclusion of an additional la… |
| 2021-03-05 |
Class II
|
Ongoing |
Z-1411-2021 |
Covidien Surgiwand" II Suction and Irrigation Device: Electrosurgical, cutting & coagulation & accessories22 Product N… |
— |
Investigations related to customer complaints received for particulate matter inside of the Surgiwand" II device tubing components identified the root cause as … |
| 2021-02-26 |
Class II
|
Ongoing |
Z-1335-2021 |
BRAVO PH CAPS DELIVERY DEV5-PK, FGS-0312/FGS-0313 - Product Usage: intended to be used for gastroesophageal pH measureme… |
— |
The capsule may fail to attach to the esophageal mucosa, which in turn may lead to the aspiration of the capsule. In the event of capsule aspiration, immediate … |
| 2021-02-26 |
Class II
|
Ongoing |
Z-1334-2021 |
CF Delivery Dev Caps Bravo x5, FGS-0635/FGS 0636 - Product Usage: intended to be used for gastroesophageal pH measuremen… |
— |
The capsule may fail to attach to the esophageal mucosa, which in turn may lead to the aspiration of the capsule. In the event of capsule aspiration, immediate … |
| 2021-01-13 |
Class II
|
Terminated |
Z-1142-2021 |
Covidien Parietex hydrophilic anatomical mesh 15 cm x 10 cm polyester left - Product Usage: designed for the repair of i… |
— |
incorrect device is contained in the package. The packaging label indicates that the device is for left side use, the product inside the package is for right si… |
| 2020-11-23 |
Class II
|
Completed |
Z-0748-2021 |
Covidien TA Auto Suture Vascular Loading Unit with DST Series Technology 30 mm- V3. Intended for abdominal, gynecologica… |
— |
May contain a damaged internal component which could impede staple deployment and result in incomplete staple formation and a non-functional staple line prevent… |
| 2020-11-23 |
Class II
|
Completed |
Z-0747-2021 |
Covidien TA Auto Suture Vascular Stapler with DST Series Technology 30mm-V 3. Intended for abdominal, gynecological, pe… |
— |
May contain a damaged internal component which could impede staple deployment and result in incomplete staple formation and a non-functional staple line prevent… |
| 2020-11-16 |
Class II
|
Ongoing |
Z-0515-2021 |
Capnostream 35 Portable Respiratory Monitor, Product numbers PM35MN02, PM35MN01, PM35MN05, DLPM35MN02 - Product Usage: … |
— |
The firm has released software update V01.05.02.16 (also known as V1.5.2) in response to customer reports of a false display of the message, "Temperature Exceed… |
| 2020-10-16 |
Class II
|
Ongoing |
Z-0425-2021 |
Puritan Bennett 980 (PB980) Ventilator Series - Product Usage: for use on patient population sizes from Neonatal (NICU) … |
— |
In-house lab observations and customer reports of overheating and/or thermal damage to the battery pack, create the risk of exposure to smoke or hazardous mate… |
| 2020-06-26 |
Class II
|
Ongoing |
Z-2769-2020 |
Beacon EUS Access System Preloaded Access 135degree Needle sterile, single-use, endoscopic ultrasound device consisting… |
— |
This voluntary recall is being conducted following three customer reports of the device cannula detaching during a procedure. In one case, the detached cannula … |
| 2020-06-26 |
Class II
|
Ongoing |
Z-2768-2020 |
Beacon EUS Access System Preloaded Access 90degree Needle sterile, single-use, endoscopic ultrasound device consisting … |
— |
This voluntary recall is being conducted following three customer reports of the device cannula detaching during a procedure. In one case, the detached cannula … |
| 2020-05-12 |
Class II
|
Ongoing |
Z-2255-2020 |
Multifire Endo Hernia 0 12mm Stapler with 4.0mm Disposable Loading Unit , Part No. 174027 - Product Usage: has applicati… |
— |
The product is recalled due to a manufacturing assembly error that may cause the staples to fail to properly advance within the staple cartridge when the instru… |
| 2020-05-12 |
Class II
|
Ongoing |
Z-2254-2020 |
Multifire Endo Hernia 0 12mm Stapler with 4.8mm Disposable Loading Unit , Part No. 174025 - Product Usage: has applicati… |
— |
The product is recalled due to a manufacturing assembly error that may cause the staples to fail to properly advance within the staple cartridge when the instru… |
| 2020-05-12 |
Class II
|
Ongoing |
Z-2253-2020 |
Multifire VersaTrack Auto Suture Hernia Stapler, 4.8mm, Part No. 174023 - Product Usage: has application in endoscopic g… |
— |
The product is recalled due to a manufacturing assembly error that may cause the staples to fail to properly advance within the staple cartridge when the instru… |
| 2020-05-12 |
Class II
|
Ongoing |
Z-2252-2020 |
Multifire VersaTrack Auto Suture Hernia Stapler, 4.0mm, Part No. 174021 - Product Usage: has application in endoscopic g… |
— |
The product is recalled due to a manufacturing assembly error that may cause the staples to fail to properly advance within the staple cartridge when the instru… |
| 2020-04-30 |
Class II
|
Terminated |
Z-1994-2020 |
Dover 400 ml 100% Silicone Silver-Hydrogel Coated Premium Urine Meter Foley Tray, 18 Fr/Ch (6.0 mm), 5 mL Catheter Pre-c… |
— |
Temperature sensing catheters failed to meet the established calibrated temperature sensing tolerance of +/- 0.2¿C. Failure to correctly measure patient body … |
| 2020-04-30 |
Class II
|
Terminated |
Z-1993-2020 |
Dover 400 ml 100% Silicone Silver-Hydrogel Coated Premium Urine Meter Foley Tray,18 Fr/Ch (6.0 mm), 5 mL Catheter Pre-co… |
— |
Temperature sensing catheters failed to meet the established calibrated temperature sensing tolerance of +/- 0.2¿C. Failure to correctly measure patient body … |
| 2020-04-30 |
Class II
|
Terminated |
Z-1992-2020 |
Dover 100% Silicone Silver-Hydrogel Coated Premium Urine Meter Foley Tray 400mL, 16 Fr/Ch (5.3 mm), 5 mL Catheter Pre-c… |
— |
Temperature sensing catheters failed to meet the established calibrated temperature sensing tolerance of +/- 0.2¿C. Failure to correctly measure patient body … |
| 2020-04-30 |
Class II
|
Terminated |
Z-1991-2020 |
Dover 100% Silicone Silver-Hydrogel Coated Premium Urine Meter Foley Tray 400mL, Premium, Urine Meter, 16 Fr/Ch (5.3 mm)… |
— |
Temperature sensing catheters failed to meet the established calibrated temperature sensing tolerance of +/- 0.2¿C. Failure to correctly measure patient body … |
| 2020-04-30 |
Class II
|
Terminated |
Z-1990-2020 |
Dover 400mL, 100% Silicone Premium Urine Meter Foley Tray, 16 Fr/Ch (5.3 mm), 5 mL Catheter Pre-connected to 2000 mL Dr… |
— |
Temperature sensing catheters failed to meet the established calibrated temperature sensing tolerance of +/- 0.2¿C. Failure to correctly measure patient body … |
| 2020-04-30 |
Class II
|
Terminated |
Z-1989-2020 |
Dover 100% Silicone Premium Urine Meter Tray 400mL, 16 Fr/Ch (5.3 mm), 5 mL Foley Catheter Pre-connected to 2000 mL Drai… |
— |
Temperature sensing catheters failed to meet the established calibrated temperature sensing tolerance of +/- 0.2¿C. Failure to correctly measure patient body … |
| 2020-04-30 |
Class II
|
Terminated |
Z-1988-2020 |
Dover 100% Silicone Premium Urine Meter Foley Tray, 400mL, 14 Fr/Ch (4.7 mm), 5 mL Catheter Pre-connected to 2000 mL Dra… |
— |
Temperature sensing catheters failed to meet the established calibrated temperature sensing tolerance of +/- 0.2¿C. Failure to correctly measure patient body … |
| 2020-04-30 |
Class II
|
Terminated |
Z-1987-2020 |
Dover 100% Silicone Silver-Hydrogel Coated Foley Catheter with Temperature Sensor 18FR 5CCCC2W, Product Code: 50518ICT -… |
— |
Temperature sensing catheters failed to meet the established calibrated temperature sensing tolerance of +/- 0.2¿C. Failure to correctly measure patient body … |
| 2020-04-30 |
Class II
|
Terminated |
Z-1986-2020 |
Dover 100% Silicone Foley Catheter with Temperature 16FR 5CC2W, Product Code: 50516T - Product Usage: for Drainage of t… |
— |
Temperature sensing catheters failed to meet the established calibrated temperature sensing tolerance of +/- 0.2¿C. Failure to correctly measure patient body … |
| 2020-04-30 |
Class II
|
Terminated |
Z-1985-2020 |
Dover 100% Silicone Silver-Hydrogel Coated Foley Catheter with Temperature Sensor 16FR 5CCCC2W, Product Code: 50516ICT … |
— |
Temperature sensing catheters failed to meet the established calibrated temperature sensing tolerance of +/- 0.2¿C. Failure to correctly measure patient body … |
| 2020-04-30 |
Class II
|
Terminated |
Z-1984-2020 |
Dover 100% Silicone Foley Catheter with Temperature Sensor 14FR 5CC2W, Product Code: 50514T - Product Usage: for Draina… |
— |
Temperature sensing catheters failed to meet the established calibrated temperature sensing tolerance of +/- 0.2¿C. Failure to correctly measure patient body … |
| 2020-02-10 |
Class II
|
Terminated |
Z-1447-2020 |
Kits containing Covidien Force TriVerse Electrosurgical Devices. Distributed in EMEA (Europe, Middle East, and Africa) o… |
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Sterile packaging may potentially be compromised, and use of products may result in increased risk for infection. |
| 2020-02-10 |
Class II
|
Terminated |
Z-1446-2020 |
Covidien Force TriVerse Electrosurgical Devices, Product numbers FT3000 and FT3000DB, UDI 10884524000084 20884524000081… |
— |
Sterile packaging may potentially be compromised, and use of products may result in increased risk for infection. |
| 2020-01-17 |
Class II
|
Terminated |
Z-1264-2020 |
Covidien Endo GIA Ultra Universal Stapler 12 mm-intended for resection, transection in general surgery Item Code: EGIAU… |
— |
Potential for the sterile barrier to be compromised. Products with a compromised sterile barrier may result in a potentially increased risk for infection |