| 2026-08-20 |
Class II
|
Ongoing |
Z-3212-2026 |
CADD Yellow Medication Cassette Reservoir with NRFit connector US Product Codes: 21-7600-24, 21-7609-24 OUS Produc… |
— |
Reservoirs may exhibit medication leakage at the joint between luer connector and tubing. Issue could result in delay or interruption of therapy, under delivery… |
| 2026-06-24 |
Class II
|
Ongoing |
Z-2759-2026 |
Hotline Fluid Warming Set, single use device, is designed to warm blood and intravenous fluids and deliver them to the p… |
— |
ICU Medical became aware of an increased likelihood of leakage in specific Lots of L-70 HOTLINE Fluid Warming Sets due to potentially inadequate solvent applica… |
| 2026-06-10 |
Class II
|
Ongoing |
Z-2724-2026 |
ICU Medical Plum Solo Precision IV Pump, v1.0.3, Item Number 400010401; infusion pump |
— |
In a specific scenario, the pump will not decrement the Volume to be Infused (VTBI) displayed on the Delivery screen and may deliver up to twice the VTBI at the… |
| 2026-06-10 |
Class II
|
Ongoing |
Z-2723-2026 |
ICU Medical Plum Duo Infusion Pump, v1.2.3: 1) Item Number 400020401 and 2) Item Number 400020403; infusion pump |
— |
In a specific scenario, the pump will not decrement the Volume to be Infused (VTBI) displayed on the Delivery screen and may deliver up to twice the VTBI at the… |
| 2025-12-19 |
Class II
|
Ongoing |
Z-1111-2026 |
Tego Connector: REF: 011-D1000, 01C-D1000, 055-D1000, D1000; Conector Tego: REF: LAT-D1000 |
— |
Needle free access device intended as accessory to vascular access used in hemodialysis or accessory to intravascular administration sets has a silicone seal wh… |
| 2025-12-19 |
Class II
|
Ongoing |
Z-1101-2026 |
Portex Spinal Tray, Item No. A3729-24 A3595 |
— |
Affected lots of syringes may have a crack on the syringe collar, which may lead to delayed or repeated blood draw/fluid delivery. This issue may also lead to b… |
| 2025-12-19 |
Class II
|
Ongoing |
Z-1100-2026 |
Pulsator Arterial Blood Sampling Kit, Item Numbers 4044EG-1 4080P-2 4084P-1 4080PE 4080PG |
— |
Affected lots of syringes may have a crack on the syringe collar, which may lead to delayed or repeated blood draw/fluid delivery. This issue may also lead to b… |
| 2025-12-15 |
Class II
|
Ongoing |
Z-1120-2026 |
ICU Medical Plum Solo Precision IV Pump, List Numbers: 400010401 (US), 400011001 (Philippines) |
— |
Plum Solo and Duo Infusion pumps include a feature, that when selected, automatically flushes the downstream line after a piggyback therapy. The programmed flus… |
| 2025-12-15 |
Class II
|
Ongoing |
Z-1119-2026 |
ICU Medical Plum Duo Precision IV Pump, List Numbers: 400020403 (US), 400021003 (Philippines) |
— |
Plum Solo and Duo Infusion pumps include a feature, that when selected, automatically flushes the downstream line after a piggyback therapy. The programmed flus… |
| 2025-12-15 |
Class II
|
Ongoing |
Z-1118-2026 |
ICU Medical Plum Duo Infusion Pump, List Numbers: 400020401 (US), 400021001 (Philippines) |
— |
Plum Solo and Duo Infusion pumps include a feature, that when selected, automatically flushes the downstream line after a piggyback therapy. The programmed flus… |
| 2025-12-15 |
Class II
|
Ongoing |
Z-1094-2026 |
Plum Duo Infusion System, List Number 40002-04-01 |
— |
ICU Medical received one lot of defective primary speakers from our supplier that may fail to produce an audible sound. If the primary speaker in your Plum Duo … |
| 2025-11-24 |
Class II
|
Ongoing |
Z-0966-2026 |
LifeShield Drug Library Management (DLM), LifeShield Infusion Safety Software Suite v2.2 Product No. 17003-02 |
— |
Software issue only allows Concentration Limits to be defined to one digit of precision past the decimal point (0.1) instead of three digits (0.001). If the use… |
| 2025-11-24 |
Class II
|
Ongoing |
Z-0965-2026 |
LifeShield Drug Library Management (DLM); LifeShield Infusion Safety Software Suite v2.2 List Number 17003-02 |
— |
For certain customers, the Change Summary review option ceases to operate as expected for any migrated library after the migration has been completed. Users mus… |
| 2025-10-02 |
Class I
|
Ongoing |
Z-0154-2026 |
IV Administration sets. 23" (58 cm) 150 mL Burette Set (Clave, Shut Off) w/Clave, Luer Lock, REF: B33359; 23" (58 cm… |
— |
IV Gravity burette administration set burette component is missing an internal shutoff valve intended to stop fluid flow, which if used may result in delay in t… |
| 2025-09-08 |
Class II
|
Ongoing |
Z-0365-2026 |
ICU Medical ChemosafeLock Vial Adapter REFs: KL-VA001U3 KL-VA002U3 KL-VA131U3 KL-VA201U3 KL-VA202U3 KL-VA321U3 |
— |
Port weld of drug transfer device may separate or break during use and potentially result in a leak. |
| 2025-09-08 |
Class II
|
Ongoing |
Z-0364-2026 |
ICU Medical ChemosafeLock Connecter REF: KL-FNU3 |
— |
Port weld of drug transfer device may separate or break during use and potentially result in a leak. |
| 2025-09-08 |
Class II
|
Ongoing |
Z-0363-2026 |
ICU Medical ChemosafeLock Bag Spike REF: KL-BS001U3 |
— |
Port weld of drug transfer device may separate or break during use and potentially result in a leak. |
| 2025-09-08 |
Class II
|
Ongoing |
Z-0362-2026 |
ICU Medical Oncology Kit w/2 ChemoLock", 13mm Closed Vial Spike w/ChemoLock" Port, ChemoLock" Bag Spike, Ext Set w/Chem… |
— |
Port weld of drug transfer device may separate or break during use and potentially result in a leak. |
| 2025-09-08 |
Class II
|
Ongoing |
Z-0361-2026 |
ICU Medical 6" (15 cm) Ext Set w/MicroClave" Clear, ChemoLock" Port, Y-Connector, Rotating Luer REF: CL4118 |
— |
Port weld of drug transfer device may separate or break during use and potentially result in a leak. |
| 2025-09-08 |
Class II
|
Ongoing |
Z-0360-2026 |
ICU Medical 7.5" (19 cm) Appx 1.5 ml, Ext Set w/ChemoLock" Port, Clamp, Graduated Adapter REF: CL3967 |
— |
Port weld of drug transfer device may separate or break during use and potentially result in a leak. |
| 2025-09-08 |
Class II
|
Ongoing |
Z-0359-2026 |
ICU Medical 31" (79 cm) Appx 3.4 ml, Admin Set w/20 Drop Integrated ChemoLock Drip Chamber, Spiros", Purple Cap, Hanger… |
— |
Port weld of drug transfer device may separate or break during use and potentially result in a leak. |
| 2025-09-08 |
Class II
|
Ongoing |
Z-0358-2026 |
ICU Medical 8" (20 cm) Ext Set w/MicroClave Clear, ChemoLock Port, Y-Connector, Rotating Luer, REF: CL-3950 |
— |
Port weld of drug transfer device may separate or break during use and potentially result in a leak. |
| 2025-09-08 |
Class II
|
Ongoing |
Z-0357-2026 |
ICU Medical ChemoLock Port w/Spiros, Red Cap REF: CL-35 |
— |
Port weld of drug transfer device may separate or break during use and potentially result in a leak. |
| 2025-09-08 |
Class II
|
Ongoing |
Z-0356-2026 |
ICU Medical Syringe Transfer Set w/MicroClave, ChemoLock Port REF: CL-34 |
— |
Port weld of drug transfer device may separate or break during use and potentially result in a leak. |
| 2025-09-08 |
Class II
|
Ongoing |
Z-0355-2026 |
ICU Medical ChemoLock w/Mini Bag Spike ¿ REF: C-17 |
— |
Port weld of drug transfer device may separate or break during use and potentially result in a leak. |
| 2025-09-08 |
Class II
|
Ongoing |
Z-0354-2026 |
ICU Medical ChemoLock Vented Vial Spike, 20mm, 20 Units ¿ REF: 011-CL-70S-20 |
— |
Port weld of drug transfer device may separate or break during use and potentially result in a leak. |
| 2025-09-08 |
Class II
|
Ongoing |
Z-0353-2026 |
ICU Medical 6.5" Bag Spike w/ChemoLock Port Additive Port, ChemoLock Port REF: CL3955 |
— |
Port weld of drug transfer device may separate or break during use and potentially result in a leak. |
| 2025-09-08 |
Class II
|
Ongoing |
Z-0352-2026 |
ICU Medical Graduated Connector w/ChemoLock Port REF: CL3900 |
— |
Port weld of drug transfer device may separate or break during use and potentially result in a leak. |
| 2025-09-08 |
Class II
|
Ongoing |
Z-0351-2026 |
ICU Medical 21" Ext Set w/ChemoLock Port, Clamp, Graduated Connector REF: CL3360 |
— |
Port weld of drug transfer device may separate or break during use and potentially result in a leak. |
| 2025-09-08 |
Class II
|
Ongoing |
Z-0350-2026 |
ICU Medical ChemoLock Port REF: CL2100 |
— |
Port weld of drug transfer device may separate or break during use and potentially result in a leak. |
| 2025-09-08 |
Class II
|
Ongoing |
Z-0349-2026 |
ICU Medical ChemoLock 13mm Closed Vial Spike REF: CL-82 |
— |
Port weld of drug transfer device may separate or break during use and potentially result in a leak. |
| 2025-09-08 |
Class II
|
Ongoing |
Z-0348-2026 |
ICU Medical ChemoLock Closed Vial Spike w/Skirt, 5 Units REF: CL-80S-5 |
— |
Port weld of drug transfer device may separate or break during use and potentially result in a leak. |
| 2025-09-08 |
Class II
|
Ongoing |
Z-0347-2026 |
ICU Medical ChemoLock Vial Spike, 20mm REF: CL-80S |
— |
Port weld of drug transfer device may separate or break during use and potentially result in a leak. |
| 2025-09-08 |
Class II
|
Ongoing |
Z-0346-2026 |
ICU Medical ChemoLock Closed Vial Spike REF: CL-80 |
— |
Port weld of drug transfer device may separate or break during use and potentially result in a leak. |
| 2025-09-08 |
Class II
|
Ongoing |
Z-0345-2026 |
ICU Medical ChemoLock Vented Vial Spike, 13mm REF: CL-72 |
— |
Port weld of drug transfer device may separate or break during use and potentially result in a leak. |
| 2025-09-08 |
Class II
|
Ongoing |
Z-0344-2026 |
ICU Medical ChemoLock Vented Vial Spike, 20mm REF: CL-70S |
— |
Port weld of drug transfer device may separate or break during use and potentially result in a leak. |
| 2025-09-08 |
Class II
|
Ongoing |
Z-0343-2026 |
ICU Medical ChemoLock Universal Vented Vial Spike REF: CL-70 |
— |
Port weld of drug transfer device may separate or break during use and potentially result in a leak. |
| 2025-09-08 |
Class II
|
Ongoing |
Z-0342-2026 |
ICU Medical Double ChemoLock Port Syringe Transfer Set REF: CL-33 |
— |
Port weld of drug transfer device may separate or break during use and potentially result in a leak. |
| 2025-09-08 |
Class II
|
Ongoing |
Z-0341-2026 |
ICU Medical ChemoLock Bag Spike REF: CL-10 |
— |
Port weld of drug transfer device may separate or break during use and potentially result in a leak. |
| 2025-09-08 |
Class II
|
Ongoing |
Z-0340-2026 |
ICU Medical 73" (185 cm) Appx 2.5 ml, Ext Set, Smallbore w/ChemoLock Port, Clamp, ChemoLock w/Red Cap REF: CL4176 |
— |
Port weld of drug transfer device may separate or break during use and potentially result in a leak. |
| 2025-09-08 |
Class II
|
Ongoing |
Z-0339-2026 |
ICU Medical 60" (152 cm) Appx 1.2 ml, Ext Set, Smallbore w/ChemoLock Port, Clamp, Spiros w/Red Cap REF: CL4173 |
— |
Port weld of drug transfer device may separate or break during use and potentially result in a leak. |
| 2025-09-08 |
Class II
|
Ongoing |
Z-0338-2026 |
ICU Medical 45" (114 cm) Appx 1.7 ml, Smallbore Ext Set w/Spiros w/Red Cap, Anti-Siphon Valve, Clamp, Y-Connector w/Che… |
— |
Port weld of drug transfer device may separate or break during use and potentially result in a leak. |
| 2025-09-08 |
Class II
|
Ongoing |
Z-0337-2026 |
ICU Medical Oncology Transfer Kit w/ChemoClave and ChemoLock Port; Spiros w/Red Cap; ChemoLock Port REF: CL4138 |
— |
Port weld of drug transfer device may separate or break during use and potentially result in a leak. |
| 2025-09-08 |
Class II
|
Ongoing |
Z-0336-2026 |
ICU Medical Oncology Kit w/ChemoLock, ChemoLock Port REF: CL4136 |
— |
Port weld of drug transfer device may separate or break during use and potentially result in a leak. |
| 2025-09-08 |
Class II
|
Ongoing |
Z-0335-2026 |
ICU Medical ChemoLock Bag Spike with Clave Additive Port REF: CL3940 |
— |
Port weld of drug transfer device may separate or break during use and potentially result in a leak. |
| 2025-09-08 |
Class II
|
Ongoing |
Z-0334-2026 |
ICU Medical Oncology Kit w/31" (79 cm) 20 Drop Admin Set w/Integrated ChemoLock" Port Drip Chamber, Spiros"; ChemoLock"… |
— |
Port weld of drug transfer device may separate or break during use and potentially result in a leak. |
| 2025-09-08 |
Class II
|
Ongoing |
Z-0333-2026 |
ICU Medical 30" (76 cm) Appx 3.6 ml, 20 Drop Admin Set w/Integrated ChemoLock Port Drip Chamber, ChemoLock w/Red Cap, … |
— |
Port weld of drug transfer device may separate or break during use and potentially result in a leak. |
| 2025-09-08 |
Class II
|
Ongoing |
Z-0332-2026 |
ICU Medical 30" (76 cm) Appx 3.3 mL, Admin Set w/20 Drop Integrated ChemoLock Drip Chamber, Spiros", Hanger, Drop-In Re… |
— |
Port weld of drug transfer device may separate or break during use and potentially result in a leak. |
| 2025-09-08 |
Class II
|
Ongoing |
Z-0331-2026 |
ICU Medical Clave Bag Spike w/ChemoLock Port REF: CL2150 |
— |
Port weld of drug transfer device may separate or break during use and potentially result in a leak. |
| 2025-09-08 |
Class II
|
Ongoing |
Z-0330-2026 |
ICU Medical ChemoLock" Port, Bulk, Non-Sterile REF: CL2100-NS |
— |
Port weld of drug transfer device may separate or break during use and potentially result in a leak. |
| 2025-09-08 |
Class II
|
Ongoing |
Z-0329-2026 |
ICU Medical Chemo Lock Universal Vented Vial Spike REF: CL-70-10 |
— |
Port weld of drug transfer device may separate or break during use and potentially result in a leak. |
| 2025-09-08 |
Class II
|
Ongoing |
Z-0328-2026 |
ChemoLock Bag Spike, 01 units REF: CL-10-10 |
— |
Port weld of drug transfer device may separate or break during use and potentially result in a leak. |
| 2025-08-06 |
Class II
|
Ongoing |
Z-2527-2025 |
Smiths Medical NRFit CADD Yellow Medication Cassette Reservoir with NRFit connector with flow stop, yellow-striped tubin… |
— |
Certain CADD 50 mL and 100 mL Medication Cassette Reservoirs may exhibit weakened medication bag welds along the bag perimeter inside the plastic housing. This… |
| 2025-08-06 |
Class II
|
Ongoing |
Z-2526-2025 |
Smiths Medical CADD Medication Cassette Reservoir with flow stop, clamp and female Luer. Non-vented stopper included. 10… |
— |
Certain CADD 50 mL and 100 mL Medication Cassette Reservoirs may exhibit weakened medication bag welds along the bag perimeter inside the plastic housing. This… |
| 2025-08-06 |
Class II
|
Ongoing |
Z-2525-2025 |
Smiths Medical CADD" Medication Cassette Reservoir with flow stop, clamp and female Luer. Non-vented stopper included. 5… |
— |
Certain CADD 50 mL and 100 mL Medication Cassette Reservoirs may exhibit weakened medication bag welds along the bag perimeter inside the plastic housing. This… |
| 2025-08-06 |
Class II
|
Ongoing |
Z-2524-2025 |
Smiths Medical CADD" Yellow Medication Cassette Reservoir with flow stop, clamp and female Luer. Non-vented stopper incl… |
— |
Certain CADD 50 mL and 100 mL Medication Cassette Reservoirs may exhibit weakened medication bag welds along the bag perimeter inside the plastic housing. This… |
| 2025-08-06 |
Class II
|
Ongoing |
Z-2523-2025 |
Smiths Medical CADD Medication Cassette Reservoir with clamp and female Luer. Non-vented stopper included. 100mL, Produ… |
— |
Certain CADD 50 mL and 100 mL Medication Cassette Reservoirs may exhibit weakened medication bag welds along the bag perimeter inside the plastic housing. This… |
| 2025-08-06 |
Class II
|
Ongoing |
Z-2522-2025 |
Smiths Medical CADD Medication Cassette Reservoir with clamp and female Luer. Nonvented stopper included. 50mL, Product… |
— |
Certain CADD 50 mL and 100 mL Medication Cassette Reservoirs may exhibit weakened medication bag welds along the bag perimeter inside the plastic housing. This… |
| 2025-07-11 |
Class I
|
Ongoing |
Z-2129-2025 |
Plum Duo Infusion System, List Number: 400020401 |
— |
ICU Medical identified two sequences of programming events and alarm interactions that may cause the user interface to become unresponsive. |
| 2025-06-03 |
Class II
|
Ongoing |
Z-2116-2025 |
SwabCap Disinfecting Cap for Needlefree Connectors: SwabSleeve, REF: SCXT3-5-2000; SwabCap, 200-ct. Box, REF: SCXT3-200… |
— |
Due to a manufacturing issue, disinfecting cap for needle-free connectors may have an incomplete seal between the foil lid and plastic container, which may resu… |
| 2025-05-02 |
Class II
|
Ongoing |
Z-1763-2025 |
LifeShield Drug Library Management (DLM), LifeShield Infusion Safety Software SUite v2.1 and v2.2 |
— |
Firm has identified Drug Library Management defects in the software: 1) DLM software does not allow user to create percentage dose rate or rate change values wi… |
| 2025-04-22 |
Class II
|
Ongoing |
Z-1991-2025 |
ICU Medical Plum Solos, Item number 400011001; infusion pump |
— |
Internal testing found that Plum Duo pumps with software version 1.1.1 have a workflow that may result in bypassing the Maximum Dose Limit alert. The Maximum D… |
| 2025-04-22 |
Class II
|
Ongoing |
Z-1990-2025 |
ICU Medical Plum Duo, Item numbers: 1) 400020401, 2) 400021001 , and 3) 400021003; infusion pump |
— |
Internal testing found that Plum Duo pumps with software version 1.1.1 have a workflow that may result in bypassing the Maximum Dose Limit alert. The Maximum D… |
| 2024-11-06 |
Class II
|
Ongoing |
Z-0652-2025 |
ChemoLock Close Vial Spike REF CL-80 The Chemolock Closed System Transfer Device prevents the transfer of environment… |
— |
Due to finished goods incorrectly packaged and labeled. |
| 2024-10-22 |
Class I
|
Ongoing |
Z-0482-2025 |
Allegedly counterfeit batteries manufactured by CSB batteries being used with Plum Infusion Systems: Plum 360" Infusion… |
— |
ICU Medical has received reports of allegedly counterfeit CSB batteries being used with Plum Infusion Systems. While these non-OEM batteries are visually simila… |
| 2024-05-07 |
Class I
|
Ongoing |
Z-2449-2024 |
Plum 360/A+ spare batteries. Item Number: SUB0000864. |
— |
Due to a manufacturing defect from the battery supplier, affected batteries may experience a loss of capacity earlier in the battery lifecycle than expected and… |
| 2024-05-07 |
Class I
|
Ongoing |
Z-2448-2024 |
Replacement Battery List Number SUB0000594 and SUB0000864 found in Plum A+ & Plum A+3 Infusion Systems, Pump List Number… |
— |
Due to a manufacturing defect from the battery supplier, affected batteries may experience a loss of capacity earlier in the battery lifecycle than expected and… |
| 2024-05-07 |
Class I
|
Ongoing |
Z-2447-2024 |
Replacement Battery List Number SUB0000864, found in Plum 360 Infusion System, List Number 30010. Product description is… |
— |
Due to a manufacturing defect from the battery supplier, affected batteries may experience a loss of capacity earlier in the battery lifecycle than expected and… |
| 2023-07-13 |
Class II
|
Ongoing |
Z-2430-2023 |
Plum 360 Infusion System, List Numbers: 300100405, 300100409, 300100413, 300100414, 300100415, 300100418, 300100451, 30… |
— |
Due to a manufacturing defect of a supplier provided component, there is a potential that the audible signal for an alarm may not sound under certain conditions… |
| 2023-03-22 |
Class I
|
Ongoing |
Z-1568-2023 |
ASM Replacement Battery, Component Number SUB0000594 |
— |
Due to a manufacturing defect from the battery supplier, affected batteries may experience a loss of capacity earlier in the battery lifecycle than expected and… |
| 2023-03-22 |
Class I
|
Ongoing |
Z-1567-2023 |
ASM Replacement Battery, Component Number SUB0000864 |
— |
Due to a manufacturing defect from the battery supplier, affected batteries may experience a loss of capacity earlier in the battery lifecycle than expected and… |
| 2023-03-22 |
Class I
|
Ongoing |
Z-1566-2023 |
Replacement Battery List Number SUB0000594 found in Plum A+ & Plum A+3 Infusion Systems, List Numbers: a) 11005, b) 1197… |
— |
Due to a manufacturing defect from the battery supplier, affected batteries may experience a loss of capacity earlier in the battery lifecycle than expected and… |
| 2023-03-22 |
Class I
|
Ongoing |
Z-1565-2023 |
Replacement Battery List Number SUB0000864, found in Plum 360 Infusion System, List Number 30010 |
— |
Due to a manufacturing defect from the battery supplier, affected batteries may experience a loss of capacity earlier in the battery lifecycle than expected and… |
| 2022-08-01 |
Class II
|
Ongoing |
Z-1724-2022 |
6" (15 cm) Appx 0.85 ml, Smallbore Trifuse Ext Set w/3 MicroClave Clear, 2 Check Valve, 3 Clamps, Rotating Luer; |
— |
Due to a manufacturing defect which results in a visible gap between the connector's top and bottom housing. |
| 2022-08-01 |
Class II
|
Ongoing |
Z-1723-2022 |
6.5 IN (17 cm) APPX 0.78 ml, EXT SET w/Clave CLEAR, Clave 4-WAY Stopcock, Spiros, RED CAP. Accessory for intravascu… |
— |
Due to a manufacturing defect which results in a visible gap between the connector's top and bottom housing. |
| 2022-08-01 |
Class II
|
Ongoing |
Z-1722-2022 |
MicroClave Clear Neutral Connector; MicroClave Clear Connector; MicroClave Clear Neutral Connector, Approx Priming… |
— |
Due to a manufacturing defect which results in a visible gap between the connector's top and bottom housing. |
| 2022-08-01 |
Class II
|
Ongoing |
Z-1721-2022 |
6.5" (17 cm) Appx 0.84 ml, Smallbore Bifuse Ext Set w/2 MicroClave Clear, 2 Check Valves, Luer Lock; |
— |
Due to a manufacturing defect which results in a visible gap between the connector's top and bottom housing. |
| 2022-08-01 |
Class II
|
Ongoing |
Z-1720-2022 |
8.5" (22 cm) Appx 0.85 ml, Bifuse Pressure Infusion (400 psig) Ext Set w/2 Remv MicroClave Clear, 2 Purple Clamps, Rotat… |
— |
Due to a manufacturing defect which results in a visible gap between the connector's top and bottom housing. |
| 2022-08-01 |
Class II
|
Ongoing |
Z-1719-2022 |
MicroClave Clear Neutral Connector. A bidirectional connector used as an accessory to an intravascular catheter placed i… |
— |
Due to a manufacturing defect which results in a visible gap between the connector's top and bottom housing. |
| 2022-06-27 |
Class II
|
Ongoing |
Z-1682-2022 |
Product Description/Item: ChemoLock Vial Spike, 20mm/011-CL-80S; ChemoLock Bag Spike/CL-10; ChemoLock w/Mini Bag Spike… |
— |
Ports have a potential for unintended disconnection, inability to connect to or fully engage with injectors, due to a variation in the spring inside the Port, w… |
| 2022-06-27 |
Class II
|
Ongoing |
Z-1681-2022 |
Product Description/Item: ChemoLock Bag Spike, 10 units/CL-10-10; ChemoLock BAG SPIKE w/ ADDITIVE PORT, DRY SPIKE/CL-12… |
— |
Ports have a potential for unintended disconnection, inability to connect to or fully engage with injectors, due to a variation in the spring inside the Port, w… |
| 2021-03-16 |
Class II
|
Ongoing |
Z-1590-2021 |
REF K7040-001 Spinning Spiros Closed Male Luer - Product Usage: provides access for the administration of fluids from a … |
— |
Due to molding defect, there is a potential that certain lots of spinning and non-spinning Sprios male luers may exhibit small amounts of leakage in the inactiv… |
| 2021-03-16 |
Class II
|
Ongoing |
Z-1589-2021 |
REF CH3762 35" (89 cm) Appx 3.9 ml, 10 Drop Admin Set w/Integrated Clave" Drip Chamber, Clave", Spiros" w/Red Cap, Bag … |
— |
Due to molding defect, there is a potential that certain lots of spinning and non-spinning Sprios male luers may exhibit small amounts of leakage in the inactiv… |
| 2021-03-16 |
Class II
|
Ongoing |
Z-1588-2021 |
REF CH3235 30" (76 cm) Appx 4.1 ml, Yellow 20 Drop Admin Set w/15 Micron Filter, Spiros" - Product Usage: provides acces… |
— |
Due to molding defect, there is a potential that certain lots of spinning and non-spinning Sprios male luers may exhibit small amounts of leakage in the inactiv… |
| 2021-03-16 |
Class II
|
Ongoing |
Z-1587-2021 |
REF CH3034 5" (13 cm) Bag Spike Adapter w/Spiros" w/Red Cap, Vented Cap - Product Usage: provides access for the admini… |
— |
Due to molding defect, there is a potential that certain lots of spinning and non-spinning Sprios male luers may exhibit small amounts of leakage in the inactiv… |
| 2021-03-16 |
Class II
|
Ongoing |
Z-1586-2021 |
REF 20130-01 Spinning Spiros¿ Closed Male Luer, Red Cap REF CH2000S-PC Spinning Spiros¿ Closed Male Luer, Purple Ca… |
— |
Due to molding defect, there is a potential that certain lots of spinning and non-spinning Sprios male luers may exhibit small amounts of leakage in the inactiv… |
| 2021-03-16 |
Class II
|
Ongoing |
Z-1585-2021 |
REF 20120-01 Spiros" Closed Male Luer - Product Usage: provides access for the administration of fluids from a contai… |
— |
Due to molding defect, there is a potential that certain lots of spinning and non-spinning Sprios male luers may exhibit small amounts of leakage in the inactiv… |
| 2021-03-16 |
Class II
|
Ongoing |
Z-1584-2021 |
REF 034-H2629 Appx 1.0 ml, Adaptador universal para sistemas IV con Spiros" - Product Usage: provides access for the adm… |
— |
Due to molding defect, there is a potential that certain lots of spinning and non-spinning Sprios male luers may exhibit small amounts of leakage in the inactiv… |
| 2021-03-16 |
Class II
|
Ongoing |
Z-1583-2021 |
REF 011-H3597 42 cm (16.5 IN) APPX 2.6ml, PUR TRANSFER SET, Clave ADDITIVE PORT, BCV, Spiros - Product Usage: provides a… |
— |
Due to molding defect, there is a potential that certain lots of spinning and non-spinning Sprios male luers may exhibit small amounts of leakage in the inactiv… |
| 2021-03-16 |
Class II
|
Ongoing |
Z-1582-2021 |
REF 011-H2864-HSR 180 cm (71 IN)APPX 11.5ml, PUR AMBR, Spiros, CAMERA, REG. FLUSSO, BCV, Y-Clave - Product Usage: provid… |
— |
Due to molding defect, there is a potential that certain lots of spinning and non-spinning Sprios male luers may exhibit small amounts of leakage in the inactiv… |
| 2021-03-16 |
Class II
|
Ongoing |
Z-1581-2021 |
REF 011-CH3967 Admin Set w/ClaveTM, SpirosTM - Product Usage: provides access for the administration of fluids from a co… |
— |
Due to molding defect, there is a potential that certain lots of spinning and non-spinning Sprios male luers may exhibit small amounts of leakage in the inactiv… |
| 2021-03-16 |
Class II
|
Ongoing |
Z-1580-2021 |
REF CH3625 5" (13 cm) Appx 0.50 ml, Smallbore Trifuse Ext Set w/3 ChemoClave (Purple, Green Rings), Spiros w/Red Cap, 3… |
— |
Due to molding defect, there is a potential that certain lots of spinning and non-spinning Sprios male luers may exhibit small amounts of leakage in the inactiv… |
| 2021-03-16 |
Class II
|
Ongoing |
Z-1579-2021 |
REF CH3020 40" (102 cm) Appx. 4.8 ml, 20 Drop Admin Set w/In-Line Chamber, 2 Spiros", Hanger - Product Usage: provides a… |
— |
Due to molding defect, there is a potential that certain lots of spinning and non-spinning Sprios male luers may exhibit small amounts of leakage in the inactiv… |
| 2021-03-16 |
Class II
|
Ongoing |
Z-1578-2021 |
REF CH3011 30" (76 cm) Appx 3.3 mL, 20 Drop Admin Set w/Integrated ChemoClave Drip Chamber, Spiros w/Red Cap, Bag Hang… |
— |
Due to molding defect, there is a potential that certain lots of spinning and non-spinning Sprios male luers may exhibit small amounts of leakage in the inactiv… |
| 2021-03-16 |
Class II
|
Ongoing |
Z-1577-2021 |
REF CH2060 60mL Syringe w/Spinning Spiros, Red Cap - Product Usage: provides access for the administration of fluids fro… |
— |
Due to molding defect, there is a potential that certain lots of spinning and non-spinning Sprios male luers may exhibit small amounts of leakage in the inactiv… |
| 2021-03-16 |
Class II
|
Ongoing |
Z-1576-2021 |
REF CH2020 20mL Syringe w/Spinning Spiros, Red Cap - Product Usage: provides access for the administration of fluids fro… |
— |
Due to molding defect, there is a potential that certain lots of spinning and non-spinning Sprios male luers may exhibit small amounts of leakage in the inactiv… |
| 2021-03-16 |
Class II
|
Ongoing |
Z-1575-2021 |
REF CL4151 45" (114 cm) Appx 1.7 ml, Smallbore Ext Set w/Spiros w/Red Cap, Anti-Siphon Valve, Clamp, Y-Connector w/Chem… |
— |
Due to molding defect, there is a potential that certain lots of spinning and non-spinning Sprios male luers may exhibit small amounts of leakage in the inactiv… |
| 2021-03-16 |
Class II
|
Ongoing |
Z-1574-2021 |
REF CL3960 Oncology Kit w/60" (152 cm) Appx 2.2 ml, Smallbore Ext Set w/w/ChemoLock Port, Clamp, Anti-Siphon Valve, Spir… |
— |
Due to molding defect, there is a potential that certain lots of spinning and non-spinning Sprios male luers may exhibit small amounts of leakage in the inactiv… |
| 2021-03-16 |
Class II
|
Ongoing |
Z-1573-2021 |
REF CL3946 Oncology Kit w/5" (13 cm) Add-On Set w/ChemoLock Additive Port, Vented Cap; ChemoLock , Spinning Spiros w/Re… |
— |
Due to molding defect, there is a potential that certain lots of spinning and non-spinning Sprios male luers may exhibit small amounts of leakage in the inactiv… |
| 2021-03-16 |
Class II
|
Ongoing |
Z-1572-2021 |
REF CL3538 Oncology Kit w/5" (13 cm) Add-On Set w/ChemoLock Additive Port, Vented Cap; ChemoLock , Spinning Spiros w/Re… |
— |
Due to molding defect, there is a potential that certain lots of spinning and non-spinning Sprios male luers may exhibit small amounts of leakage in the inactiv… |
| 2021-03-16 |
Class II
|
Ongoing |
Z-1571-2021 |
REF CL3028T 30" (76 cm) Appx 6.1 ml, 20 Drop Admin Set w/Integrated w/ChemoLock Drip Chamber, 0.2 Micron Filter, Spiros … |
— |
Due to molding defect, there is a potential that certain lots of spinning and non-spinning Sprios male luers may exhibit small amounts of leakage in the inactiv… |
| 2021-03-16 |
Class II
|
Ongoing |
Z-1570-2021 |
REF CL3011 30" (76 cm) Appx 3.3 ml, 20 Drop Admin Set w/Integrated w/ChemoLock Drip Chamber, Spiros w/Red Cap, Hanger - … |
— |
Due to molding defect, there is a potential that certain lots of spinning and non-spinning Sprios male luers may exhibit small amounts of leakage in the inactiv… |
| 2021-03-16 |
Class II
|
Ongoing |
Z-1569-2021 |
REF Spinning Spiros Closed Male Luer - Product Usage: provides access for the administration of fluids from a container… |
— |
Due to molding defect, there is a potential that certain lots of spinning and non-spinning Sprios male luers may exhibit small amounts of leakage in the inactiv… |
| 2021-03-16 |
Class II
|
Ongoing |
Z-1568-2021 |
REF 20130-01 Spinning Spiros Closed Male Luer, Red Cap - Product Usage: provides access for the administration of fluid… |
— |
Due to molding defect, there is a potential that certain lots of spinning and non-spinning Sprios male luers may exhibit small amounts of leakage in the inactiv… |
| 2021-03-16 |
Class II
|
Ongoing |
Z-1567-2021 |
REF 20124-01 30" (76 cm) Appx 3.2 ml, 20 Drop Admin Set w/Integrated Clave Drip Chamber, Spiros, Bag Hanger LOT 514297… |
— |
Due to molding defect, there is a potential that certain lots of spinning and non-spinning Sprios male luers may exhibit small amounts of leakage in the inactiv… |
| 2021-03-16 |
Class II
|
Ongoing |
Z-1566-2021 |
REF CH3582 5 IN (13cm) APPX 0.57 ml, EXT SET, ANTI-SHIPHON VALVE, Spiros LOT 5125197 - Product Usage: for use in the pre… |
— |
Due to molding defect, there is a potential that certain lots of spinning and non-spinning Sprios male luers may exhibit small amounts of leakage in the inactiv… |
| 2021-03-16 |
Class II
|
Ongoing |
Z-1565-2021 |
REF CH3397 Oncology Kit w/Spiros¿, Red Cap, Bag Spike w/Clave Additive Port LOT 5118610 - Product Usage: for use in the … |
— |
Due to molding defect, there is a potential that certain lots of spinning and non-spinning Sprios male luers may exhibit small amounts of leakage in the inactiv… |
| 2020-12-02 |
Class II
|
Terminated |
Z-0958-2021 |
154 cm (61 IN) APPX 1.5ml, PUR YELLOW EXT, 1.2 MICRON FILTER - Product Usage: The intravascular administration set is a … |
— |
Due to the incorrect filter assembly. |
| 2020-12-02 |
Class II
|
Terminated |
Z-0957-2021 |
7 IN (18cm) APPX 0.43ml, SMALLBORE SET, MicroCLAVE, FILTER SetSource - Product Usage: The intravascular administration s… |
— |
Due to the incorrect filter assembly. |
| 2020-12-02 |
Class II
|
Terminated |
Z-0956-2021 |
60" (152 cm) Appx 1.9 ml, Smallbore Ext Set w/MicroClave¿ Clear, 1.2 Micron Filter, 2 Clamps, Luer Lock REF MC330174 - P… |
— |
Due to the incorrect filter assembly. |
| 2020-12-02 |
Class II
|
Terminated |
Z-0955-2021 |
60 IN (152cm) APPX 1.5 ml, PUR YELLOW SMALLBORE SET, FILTER REF B2209 - Product Usage: The intravascular administration … |
— |
Due to the incorrect filter assembly. |
| 2020-11-09 |
Class II
|
Terminated |
Z-0859-2021 |
icumedical Cogent" Hemodynamic Monitoring System - Product Usage: intended for patients for whom the monitoring of conti… |
— |
Due to a potential software issue, the display may show the incorrect continuous cardiac output (CCO) values after PulseCO calibration. |
| 2020-08-31 |
Class II
|
Ongoing |
Z-0711-2021 |
26 IN(66 cm) APPX 3.4ml, 10 DROP BLOOD SET, 170 MICRON FILTER, Spiros, REF: Z2795 |
— |
Potential for spinning versions of male luers to exhibit leaks due to a molding defect. Fluid leakage may potentially cause delay of infusion, contamination of … |
| 2020-08-31 |
Class II
|
Ongoing |
Z-0710-2021 |
Appx 1.7 ml Bag Spike w/Integrated Clave, 2 Drop-In Spiros, REF: CH3260 |
— |
Potential for spinning versions of male luers to exhibit leaks due to a molding defect. Fluid leakage may potentially cause delay of infusion, contamination of … |
| 2020-08-31 |
Class II
|
Ongoing |
Z-0709-2021 |
Spinning Spiros Closed Male Luer, Red Cap, REF: IB-CH2000SC; 5" (13 cm) Appx 1.5 ml, Add-On Set w/Spiros, REF: IB-CH3034… |
— |
Potential for spinning versions of male luers to exhibit leaks due to a molding defect. Fluid leakage may potentially cause delay of infusion, contamination of … |
| 2020-08-31 |
Class II
|
Ongoing |
Z-0708-2021 |
76 cm (30") Appx 3.3 ml, Admin Set, 2 Spiros w/Red Cap, 20 Drop In-Line Drip Chamber w/15 Micron Filter, Bag Hanger, REF… |
— |
Potential for spinning versions of male luers to exhibit leaks due to a molding defect. Fluid leakage may potentially cause delay of infusion, contamination of … |
| 2020-08-31 |
Class II
|
Ongoing |
Z-0707-2021 |
31" (78 cm) Appx 3.4 ml, Admin Set w/20 Drop Integrated ChemoLock Drip Chamber, Spiros, Bag Hanger, REF: 011-CL3011; 40"… |
— |
Potential for spinning versions of male luers to exhibit leaks due to a molding defect. Fluid leakage may potentially cause delay of infusion, contamination of … |
| 2020-08-31 |
Class II
|
Ongoing |
Z-0706-2021 |
Spiros CLOSED MALE LUER w/RED CAP, 25 UNITS, REF: 011-CH2000SC-25; 76 cm (30") Appx 3.2 ml, 20 Drop Admin Set w/Integrat… |
— |
Potential for spinning versions of male luers to exhibit leaks due to a molding defect. Fluid leakage may potentially cause delay of infusion, contamination of … |
| 2020-08-31 |
Class II
|
Ongoing |
Z-0705-2021 |
30" (76 cm) Appx 5.5 mL 20 Drop Admin Set w/Integrated Clave Drip Chamber, 1.2 Micron Filter, Spiros, Bag Hanger, REF: … |
— |
Potential for spinning versions of male luers to exhibit leaks due to a molding defect. Fluid leakage may potentially cause delay of infusion, contamination of … |
| 2020-08-31 |
Class II
|
Ongoing |
Z-0704-2021 |
3mL Syringe w/Spinning Spiros, Red Cap, REF: CH2003; 5mL Syringe w/Spinning Spiros, Red Cap, REF: CH2005; 10mL Syringe w… |
— |
Potential for spinning versions of male luers to exhibit leaks due to a molding defect. Fluid leakage may potentially cause delay of infusion, contamination of … |
| 2020-08-31 |
Class II
|
Ongoing |
Z-0703-2021 |
30" (76 cm) Appx 3.3 ml, 20 Drop Admin Set w/Integrated ChemoLock Drip Chamber, Spiros w/Red Cap, Hanger, REF: CL3011; 3… |
— |
Potential for spinning versions of male luers to exhibit leaks due to a molding defect. Fluid leakage may potentially cause delay of infusion, contamination of … |
| 2020-08-31 |
Class II
|
Ongoing |
Z-0702-2021 |
30" (76 cm) Appx 3.2 ml, 20 Drop Admin Set w/Integrated Clave Drip Chamber, Spiros, Bag Hanger, REF: 20124-01; Spinning … |
— |
Potential for spinning versions of male luers to exhibit leaks due to a molding defect. Fluid leakage may potentially cause delay of infusion, contamination of … |
| 2020-08-31 |
Class II
|
Ongoing |
Z-0701-2021 |
5 IN (13 cm) Appx 1.5 ml, Bag Spike Adapter, Spiros, REF: 20123-01; 75" (191 cm) Appx 9.1 ml, 20 Drop Admin Set w/ Integ… |
— |
Potential for spinning versions of male luers to exhibit leaks due to a molding defect. Fluid leakage may potentially cause delay of infusion, contamination of … |
| 2020-08-31 |
Class II
|
Ongoing |
Z-0700-2021 |
Spinning Spiros, Closed Male Luer, REF: 060-CH2000S; SURPLUG ChemoAccess Closed Male Luer, REF: 066-CH2000S; SURPLUG Che… |
— |
Potential for spinning versions of male luers to exhibit leaks due to a molding defect. Fluid leakage may potentially cause delay of infusion, contamination of … |
| 2020-08-31 |
Class II
|
Ongoing |
Z-0699-2021 |
42 IN (107 cm) Appx 5.0 ml, 20 Drop Admin Set, Spiros, REF: 20131-01; 31" (79 cm) Admin Set w/20 Drop Integrated Clave D… |
— |
Potential for spinning versions of male luers to exhibit leaks due to a molding defect. Fluid leakage may potentially cause delay of infusion, contamination of … |
| 2020-07-06 |
Class II
|
Terminated |
Z-0280-2021 |
SURPLUG Nano Connector.1 unit per pouch, 100 multivac pouches per case. UDI:(01)54987892069913(17)221201(30)100(10)44764… |
— |
Identification of a potential manufacturing defect on the internal surface of the NanoClave within specific lots of NanoClave sets, which may inhibit a proper… |
| 2020-07-06 |
Class II
|
Terminated |
Z-0279-2021 |
10 IN (25cm) APPX 1.1ml, SMALLBORE EXT w/3-Port NanoClave Manifold, Check Valve. 1 unit per pouch, 50 pouches per case. … |
— |
Identification of a potential manufacturing defect on the internal surface of the NanoClave within specific lots of NanoClave sets, which may inhibit a proper… |
| 2020-07-06 |
Class II
|
Terminated |
Z-0278-2021 |
5.5" (14 cm) Appx 0.28 ml, Smallbore Ext Set w/NanoClave, Clamp, Luer Lock. 1 unit per pouch, 50 multivac pouches per ca… |
— |
Identification of a potential manufacturing defect on the internal surface of the NanoClave within specific lots of NanoClave sets, which may inhibit a proper… |
| 2020-07-06 |
Class II
|
Terminated |
Z-0277-2021 |
7 IN(18 cm)APPX 1.2ml. EXT SET, NanoClave T-CONNECTOR, CLAMP, ROTATING LUER. 1 unit per pouch, 50 pouches per case. UDI:… |
— |
Identification of a potential manufacturing defect on the internal surface of the NanoClave within specific lots of NanoClave sets, which may inhibit a proper… |
| 2020-07-06 |
Class II
|
Terminated |
Z-0276-2021 |
8" (20 cm) Appx 0.33 ml, Smallbore Ext Set w/MicroClave Clear, NanoClave Clamp, Rotating Luer.1 unit per pouch, 50 multi… |
— |
Identification of a potential manufacturing defect on the internal surface of the NanoClave within specific lots of NanoClave sets, which may inhibit a proper… |
| 2020-07-06 |
Class II
|
Terminated |
Z-0275-2021 |
226 cm (89 IN) APPX 2.7ml, MicroClave Clear, 1.2v FILTER Nanoclave T-CONN. 1 unit per pouch, 50 pouches per case. UDI:… |
— |
Identification of a potential manufacturing defect on the internal surface of the NanoClave within specific lots of NanoClave sets, which may inhibit a proper… |
| 2020-07-06 |
Class II
|
Terminated |
Z-0274-2021 |
58cm (23 IN) APPX 2.1 ml EXT SET Smallbore PUR Yellow w/6-Port Clave, Clave, 2 Clave Stopcock. 1 unit per pouch, 50 pouc… |
— |
Identification of a potential manufacturing defect on the internal surface of the NanoClave within specific lots of NanoClave sets, which may inhibit a proper… |
| 2020-07-06 |
Class II
|
Terminated |
Z-0273-2021 |
PROXIMALE, 28 cm (11 IN) APPX 1.0ml, EXT Set, 6-PORT NanoClave MANIFOLD, NanoClave. 1 unit per pouch, 50 pouches per cas… |
— |
Identification of a potential manufacturing defect on the internal surface of the NanoClave within specific lots of NanoClave sets, which may inhibit a proper… |
| 2020-07-06 |
Class II
|
Terminated |
Z-0272-2021 |
APPX 0.75ml, 6-Port NanoClave Manifold (Glow, Red, Blue, Purple, Yellow Rings)BCV. 1 unit per pouch, 50 pouches per case… |
— |
Identification of a potential manufacturing defect on the internal surface of the NanoClave within specific lots of NanoClave sets, which may inhibit a proper… |
| 2020-07-06 |
Class II
|
Terminated |
Z-0272-2021 |
APPX 0.75ml, 6-Port NanoClave Manifold (Glow, Red, Blue, Purple, Yellow Rings)BCV. 1 unit per pouch, 50 pouches per case… |
— |
Identification of a potential manufacturing defect on the internal surface of the NanoClave within specific lots of NanoClave sets, which may inhibit a proper… |
| 2020-07-06 |
Class II
|
Terminated |
Z-0271-2021 |
DISTALE - 203 cm (80") Bifuse Ext Set w/6 Gang 1o2 Manifold, 8 MicroClave Clear (Green Rings), Back Check Valve, 3-Port… |
— |
Identification of a potential manufacturing defect on the internal surface of the NanoClave within specific lots of NanoClave sets, which may inhibit a proper… |
| 2020-07-06 |
Class II
|
Terminated |
Z-0270-2021 |
165cm (65 IN)APPX 2.2ml, PUR EXT SET, 3-PORT NanoClave MANIFOLD, BCV, NanoClave. 1 unit per pouch, 50 pouches per case. … |
— |
Identification of a potential manufacturing defect on the internal surface of the NanoClave within specific lots of NanoClave sets, which may inhibit a proper… |
| 2020-07-06 |
Class II
|
Terminated |
Z-0269-2021 |
20 cm (8 IN) APPX 1.0ml, PUR EXT SET, 3-PORT, NanoClave MANIFOLD, BCV, NanoClave.1 unit per pouch, 50 pouches per case. … |
— |
Identification of a potential manufacturing defect on the internal surface of the NanoClave within specific lots of NanoClave sets, which may inhibit a proper… |
| 2020-07-06 |
Class II
|
Terminated |
Z-0268-2021 |
15 cm (6 IN) Appx 1.1 ml, Smallbore Quadfuse Ext Set w/4 NanoClave 3 BCV RLL.1 unit per pouch, 50 pouches per case. UD… |
— |
Identification of a potential manufacturing defect on the internal surface of the NanoClave within specific lots of NanoClave sets, which may inhibit a proper… |
| 2020-07-06 |
Class II
|
Terminated |
Z-0267-2021 |
135 cm (53") Ext Set w/Remv 5 Gang Stopcock, Baseplate w/7 NanoClave, 4-Way Stopcock, Rotating Luer, 1 Ext..1 unit per p… |
— |
Identification of a potential manufacturing defect on the internal surface of the NanoClave within specific lots of NanoClave sets, which may inhibit a proper… |
| 2020-07-06 |
Class II
|
Terminated |
Z-0266-2021 |
8 IN(20cm) APPX 0.46ml, MicroClave CLEAR, NanoClave T-CONN, FILTER. 1 unit per pouch, 50 pouches per case. UDI: (01)108… |
— |
Identification of a potential manufacturing defect on the internal surface of the NanoClave within specific lots of NanoClave sets, which may inhibit a proper… |
| 2020-07-06 |
Class II
|
Terminated |
Z-0265-2021 |
7" (18 cm) Appx 0.29 ml, Smallbore Ext Set w/MicroClave Clear, NanoClave, Clamp, Rotating Luer. 1 unit per pouch, 50 mul… |
— |
Identification of a potential manufacturing defect on the internal surface of the NanoClave within specific lots of NanoClave sets, which may inhibit a proper… |
| 2020-07-06 |
Class II
|
Terminated |
Z-0264-2021 |
11 IN(28cm)APPX 0.7ml,SMALLBORE, 2 NanoClave, Filter. 1 unit per pouch, 50 pouches per case. UDI: ¿(01)10840619059801(… |
— |
Identification of a potential manufacturing defect on the internal surface of the NanoClave within specific lots of NanoClave sets, which may inhibit a proper… |
| 2020-07-06 |
Class II
|
Terminated |
Z-0263-2021 |
NanoClave Connector. 1 unit per pouch, 100 multivac pouches per case. UDI:(01)10840619060906(17)250101(30)100(10)455947… |
— |
Identification of a potential manufacturing defect on the internal surface of the NanoClave within specific lots of NanoClave sets, which may inhibit a proper… |
| 2020-07-06 |
Class II
|
Terminated |
Z-0262-2021 |
8 IN (20CM) APPX 1.3ml, EXT SET w/3-Port NanoClave Manifold, Check Valve.1 unit per pouch, 50 pouches per case. UDI:(0… |
— |
Identification of a potential manufacturing defect on the internal surface of the NanoClave within specific lots of NanoClave sets, which may inhibit a proper… |
| 2020-07-06 |
Class II
|
Terminated |
Z-0261-2021 |
NanoClave Connector. 1 unit per pouch, 100 multivac pouches per case. UDI:(01)10887709058757(17)250101(30)100(10)457327… |
— |
Identification of a potential manufacturing defect on the internal surface of the NanoClave within specific lots of NanoClave sets, which may inhibit a proper… |
| 2020-07-06 |
Class II
|
Terminated |
Z-0260-2021 |
124" (315 cm) 60 Drop 150 mL Burette Set (w/Clave, Shut-Off), Remv 2 Gang Clave Stopcocks, 2 Clave, Rotating Luer, 2 Ext… |
— |
Identification of a potential manufacturing defect on the internal surface of the NanoClave within specific lots of NanoClave sets, which may inhibit a proper… |
| 2020-07-06 |
Class II
|
Terminated |
Z-0259-2021 |
5.5" (14 cm) Appx 0.39 ml, Smallbore Trifuse Ext Set w/3 MicroClave Clear, NanoClave T-Connector, 3 Clamps, Rotating Lue… |
— |
Identification of a potential manufacturing defect on the internal surface of the NanoClave within specific lots of NanoClave sets, which may inhibit a proper… |
| 2020-07-06 |
Class II
|
Terminated |
Z-0258-2021 |
112" (284 cm) 60 Drop 150ml Burette Set (Clave, Shut-Off) w/2 MicroClave, Remv 3 Gang 4-Way Clave Stopcock, Check Valve,… |
— |
Identification of a potential manufacturing defect on the internal surface of the NanoClave within specific lots of NanoClave sets, which may inhibit a proper… |
| 2020-07-06 |
Class II
|
Terminated |
Z-0257-2021 |
98 IN (249cm) APPX 8.4 ml, 60 Drop Set, 2 Clave, REMV 2 Clave STOPCOCKS. 1 unit per pouch, 25 pouches per case. UDI:(01)… |
— |
Identification of a potential manufacturing defect on the internal surface of the NanoClave within specific lots of NanoClave sets, which may inhibit a proper… |
| 2020-07-06 |
Class II
|
Terminated |
Z-0256-2021 |
149 IN (378cm) APPX 19.1 ml, 15 DROP SET, 3 Clave, REMV 3 GANG 4-WAY Clave STOPCOCK 2 EXT. 1 unit per pouch, 25 pouches … |
— |
Identification of a potential manufacturing defect on the internal surface of the NanoClave within specific lots of NanoClave sets, which may inhibit a proper… |
| 2020-07-06 |
Class II
|
Terminated |
Z-0255-2021 |
148 IN (376cm) APPX 18.8 ml, 15 DROP SET, 2 CLAVE, Remv 3 Gang Clave Stopcock.1 unit per pouch, 25 pouches per case. UDI… |
— |
Identification of a potential manufacturing defect on the internal surface of the NanoClave within specific lots of NanoClave sets, which may inhibit a proper… |
| 2020-07-06 |
Class II
|
Terminated |
Z-0254-2021 |
22" (56 cm) Appx 2.5 ml, Ext Set w/4-Way Clave Stopcock, Clamp, Luer Lock. 1 unit per pouch, 50 multivac pouches per cas… |
— |
Identification of a potential manufacturing defect on the internal surface of the NanoClave within specific lots of NanoClave sets, which may inhibit a proper… |
| 2020-07-06 |
Class II
|
Terminated |
Z-0253-2021 |
60 IN(152cm) APPX 0.85ml, SMALLBORE, CLAVE STOPCOCK, MicroCLAVE CLEAR. 1 unit per pouch, 50 pouches per case. UDI:(01)10… |
— |
Identification of a potential manufacturing defect on the internal surface of the NanoClave within specific lots of NanoClave sets, which may inhibit a proper… |
| 2020-07-06 |
Class II
|
Terminated |
Z-0252-2021 |
120 IN (305cm)APPX 15.4ml, 10 DROP, 2 Clave STOPCOCK, NanoClave T-Connector, 2 CHECK VALVES. 1 unit per pouch, 50 pouche… |
— |
Identification of a potential manufacturing defect on the internal surface of the NanoClave within specific lots of NanoClave sets, which may inhibit a proper… |
| 2020-07-06 |
Class II
|
Terminated |
Z-0251-2021 |
60 IN (152cm) APPX 1.1ml, TRIFUSE, Clave STOPCOCK, 2 Clave, FILTER. 1 unit per pouch, 50 pouches per case. UDI:(01)10887… |
— |
Identification of a potential manufacturing defect on the internal surface of the NanoClave within specific lots of NanoClave sets, which may inhibit a proper… |
| 2020-07-06 |
Class II
|
Terminated |
Z-0250-2021 |
Clave Stopcock. 1 unit per pouch, 50 multivac pouches per case. UDI:(01)10887709039916(17)250201(30)50(10)4727496. … |
— |
Identification of a potential manufacturing defect on the internal surface of the NanoClave within specific lots of NanoClave sets, which may inhibit a proper… |
| 2020-07-06 |
Class II
|
Terminated |
Z-0249-2021 |
6 IN (15 cm) Ext Set, MicroClave Clear, T-Connector, RLL, Approx PV: 0.86 mL.1 unit per pouch, 50 pouches per case. UD… |
— |
Identification of a potential manufacturing defect on the internal surface of the NanoClave within specific lots of NanoClave sets, which may inhibit a proper… |
| 2020-07-06 |
Class II
|
Terminated |
Z-0248-2021 |
6.5 IN (17 cm) APPX 0.78 ml, Ext Set w/Clave Clear, Clave 4-Way Stopcock, Spiros Red Cap;1 unit per pouch, 50 pouches pe… |
— |
Identification of a potential manufacturing defect on the internal surface of the NanoClave within specific lots of NanoClave sets, which may inhibit a proper… |
| 2020-07-06 |
Class II
|
Terminated |
Z-0247-2021 |
7 IN (18CM) APPX 0.26ml, SMALLBORE EXT SET, MicroClave, Clave T-Connector.1 unit per pouch, 50 pouches per case. UDI: (0… |
— |
Identification of a potential manufacturing defect on the internal surface of the NanoClave within specific lots of NanoClave sets, which may inhibit a proper… |
| 2020-07-06 |
Class II
|
Terminated |
Z-0246-2021 |
40 (102cm) Appx 4.4ml Ext Set, 4-Way Clave Stopcock, Clave, 2 Clamps, Rotating Luer, 1 Ext. 1 unit per pouch, 50 multiv… |
— |
Identification of a potential manufacturing defect on the internal surface of the NanoClave within specific lots of NanoClave sets, which may inhibit a proper… |
| 2020-07-06 |
Class II
|
Terminated |
Z-0245-2021 |
126 IN (320cm) APPX 23.5ml, 10 Drop Set 3 Clave, Remv Clave Stopcock, 2 Ext.1 unit per pouch, 25 pouches per case. UD… |
— |
Identification of a potential manufacturing defect on the internal surface of the NanoClave within specific lots of NanoClave sets, which may inhibit a proper… |
| 2020-07-06 |
Class II
|
Terminated |
Z-0244-2021 |
128" (325 cm) Appx 16.6 ml, 15 Drop Primary Set w/2 MicroClave, Remv 2 Gang 4-Way Clave Stopcock, Rotating Luer, 2 Ext. … |
— |
Identification of a potential manufacturing defect on the internal surface of the NanoClave within specific lots of NanoClave sets, which may inhibit a proper… |
| 2020-07-06 |
Class II
|
Terminated |
Z-0243-2021 |
78" (198 cm) APPX 1.7ml, EXT SET, MicroClave Clear, 6-PORT NanoClave MANIFOLD, FILTER .1 unit per pouch, 50 pouches per … |
— |
Identification of a potential manufacturing defect on the internal surface of the NanoClave within specific lots of NanoClave sets, which may inhibit a proper… |
| 2020-07-06 |
Class II
|
Terminated |
Z-0242-2021 |
11 IN (28cm) APPX 1.5ml EXT SET NanoClave, 6-Port NanoClave Manifold . 1 unit per pouch, 50 pouches per case. UDI:¿(01… |
— |
Identification of a potential manufacturing defect on the internal surface of the NanoClave within specific lots of NanoClave sets, which may inhibit a proper… |
| 2020-07-06 |
Class II
|
Terminated |
Z-0241-2021 |
6 IN (15cm) APPX 0.89ml, Smallbore Set 6-Port NanoClave Manifold.1 unit per pouch, 50 pouches per case. UDI:(01)10887709… |
— |
Identification of a potential manufacturing defect on the internal surface of the NanoClave within specific lots of NanoClave sets, which may inhibit a proper… |
| 2020-07-06 |
Class II
|
Terminated |
Z-0240-2021 |
11 IN(28cm)APPX 0.97ml,SMALLBORE SET,NanoClave,6-PORT NanoClave MANIFOLD,BCV.1 unit per pouch, 50 pouches per case. UDI… |
— |
Identification of a potential manufacturing defect on the internal surface of the NanoClave within specific lots of NanoClave sets, which may inhibit a proper… |
| 2020-07-06 |
Class II
|
Terminated |
Z-0239-2021 |
APPX 0.75 ml, 6-Port NanoClave Manifold, Check Valve. 1 unit per pouch, 50 pouches per case. UDI:(01)10887709070551(17)… |
— |
Identification of a potential manufacturing defect on the internal surface of the NanoClave within specific lots of NanoClave sets, which may inhibit a proper… |
| 2020-07-06 |
Class II
|
Terminated |
Z-0238-2021 |
11" (28 cm) Appx 1.7 ml, Ext Set w/6-Port NanoClave Manifold, Check Valve, Clamp, NanoClave 4-Way Stopcock, Rotating Lue… |
— |
Identification of a potential manufacturing defect on the internal surface of the NanoClave within specific lots of NanoClave sets, which may inhibit a proper… |
| 2020-07-06 |
Class II
|
Terminated |
Z-0237-2021 |
20 IN(51cm) APPX 2.5ml, Ext w/6-Port NanoClave Manifold, Check Valve.1 unit per pouch, 50 pouches per case. UDI:(01)10… |
— |
Identification of a potential manufacturing defect on the internal surface of the NanoClave within specific lots of NanoClave sets, which may inhibit a proper… |
| 2020-07-06 |
Class II
|
Terminated |
Z-0236-2021 |
7 IN (18cm) APPX 1.2ml Ext Set w/6-Port NanoClave Manifold, Check Valve. 1 unit per pouch, 50 pouches per case. UDI:… |
— |
Identification of a potential manufacturing defect on the internal surface of the NanoClave within specific lots of NanoClave sets, which may inhibit a proper… |
| 2020-07-06 |
Class II
|
Terminated |
Z-0235-2021 |
10 IN (25cm) APPX 1.5ml EXT w/6-Port NanoClave Manifold, Check Valve. 1 unit per pouch, 50 pouches per case. UDI:(01)1… |
— |
Identification of a potential manufacturing defect on the internal surface of the NanoClave within specific lots of NanoClave sets, which may inhibit a proper… |
| 2020-07-06 |
Class II
|
Terminated |
Z-0234-2021 |
47 IN (119cm) APPX 6.7 ml, EXT, STOPCOCK, 3-Port NanoClave MANIFOLD, MicroClave Clear. 1 unit per pouch, 25 pouches per … |
— |
Identification of a potential manufacturing defect on the internal surface of the NanoClave within specific lots of NanoClave sets, which may inhibit a proper… |
| 2020-07-06 |
Class II
|
Terminated |
Z-0233-2021 |
139" (353 cm) 15 Drop Admin Set w/3 MicroClave Clear, 4-Way Stopcock, 3-Port NanoClave Manifold w/Check Valve, Spin Luer… |
— |
Identification of a potential manufacturing defect on the internal surface of the NanoClave within specific lots of NanoClave sets, which may inhibit a proper… |
| 2020-07-06 |
Class II
|
Terminated |
Z-0232-2021 |
58 IN (147cm) APPX 8.0 ml, 3 Port NanoClave Manifold NanoClave Stopcock, MicroClave Clear.1 unit per pouch, 25 pouches … |
— |
Identification of a potential manufacturing defect on the internal surface of the NanoClave within specific lots of NanoClave sets, which may inhibit a proper… |
| 2020-07-06 |
Class II
|
Terminated |
Z-0231-2021 |
10 IN (25cm) APPX 1.5ml, Ext w/3-Port NanoClave Manifold, Check Valve. 1 unit per pouch, 50 pouches per case. UDI:… |
— |
Identification of a potential manufacturing defect on the internal surface of the NanoClave within specific lots of NanoClave sets, which may inhibit a proper… |
| 2020-07-06 |
Class II
|
Terminated |
Z-0230-2021 |
114" (290 cm) 60 Drop 150ml Burette Set (Clave, Shut Off, Filter) w/4 Clave Remv 3-Port NanoClave Manifold, 2 Check Valv… |
— |
Identification of a potential manufacturing defect on the internal surface of the NanoClave within specific lots of NanoClave sets, which may inhibit a proper… |
| 2020-07-06 |
Class II
|
Terminated |
Z-0229-2021 |
78 IN (198cm) APPX 10.0 ml, 20 Drop Set 3-Port NanoClave Manifold, BCV, MicroClave. 1 unit per pouch, 24 pouches per cas… |
— |
Identification of a potential manufacturing defect on the internal surface of the NanoClave within specific lots of NanoClave sets, which may inhibit a proper… |
| 2020-07-06 |
Class II
|
Terminated |
Z-0228-2021 |
112 IN (284cm) APPX 14.8ml, 15 Drop Set 3 MicroClave, Remv 3-Port NanoClave Manifold, BCV.1 unit per pouch, 25 pouches p… |
— |
Identification of a potential manufacturing defect on the internal surface of the NanoClave within specific lots of NanoClave sets, which may inhibit a proper… |
| 2020-07-06 |
Class II
|
Terminated |
Z-0227-2021 |
142 IN (361cm) APPX 18.8 ml, 15 DROP SET 4 MicroClave CLEAR, REMV 3-PORT NanoClave w/ BCV. 1 unit per pouch, 25 pouches … |
— |
Identification of a potential manufacturing defect on the internal surface of the NanoClave within specific lots of NanoClave sets, which may inhibit a proper… |
| 2020-07-06 |
Class II
|
Terminated |
Z-0226-2021 |
112 IN(284cm) APPX 14.6ml, 15 Drop Set 3 MicroClave, 3-Port NanoClave Manifold, BCV.1 unit per pouch, 25 pouches per cas… |
— |
Identification of a potential manufacturing defect on the internal surface of the NanoClave within specific lots of NanoClave sets, which may inhibit a proper… |
| 2020-07-06 |
Class II
|
Terminated |
Z-0225-2021 |
112 IN (284cm) APPX 14.7ml 15 DROP SET 2 MicroClave, Remv 3-Port NanoClave Manifold, BCV.1 unit per pouch, 25 pouches pe… |
— |
Identification of a potential manufacturing defect on the internal surface of the NanoClave within specific lots of NanoClave sets, which may inhibit a proper… |
| 2020-07-06 |
Class II
|
Terminated |
Z-0224-2021 |
3-Port NanoClave Manifold w/Check Valve, Rotating Luer. 1 unit per pouch, 50 pouches per case. UDI:(01)10887709087153(1… |
— |
Identification of a potential manufacturing defect on the internal surface of the NanoClave within specific lots of NanoClave sets, which may inhibit a proper… |
| 2020-07-06 |
Class II
|
Terminated |
Z-0223-2021 |
26 IN(66cm) APPX 3.9 ml, SET, 3-Port NanoClave Manifold, Check Valve, 2 MicroClave;1 unit per pouch, 50 pouches per case… |
— |
Identification of a potential manufacturing defect on the internal surface of the NanoClave within specific lots of NanoClave sets, which may inhibit a proper… |
| 2020-07-06 |
Class II
|
Terminated |
Z-0222-2021 |
123 IN (312cm) APPX 16.1 ml, 10 DROP SET w/3 MicroClave, 3-Port NanoClave; UDI:(01)10887709085432(17)241201(30)25(10)453… |
— |
Identification of a potential manufacturing defect on the internal surface of the NanoClave within specific lots of NanoClave sets, which may inhibit a proper… |
| 2020-07-06 |
Class II
|
Terminated |
Z-0221-2021 |
83" (211 cm) Smallbore Ext Set w/Remv 8 Gang 4-Way NanoClave¿ Stopcock w/Baseplate, Rotating Luer;1 unit per pouch, 25 p… |
— |
Identification of a potential manufacturing defect on the internal surface of the NanoClave within specific lots of NanoClave sets, which may inhibit a proper… |
| 2020-07-06 |
Class II
|
Terminated |
Z-0220-2021 |
Appx 0.82 ml, 3 Gang 4-Way NanoClave¿ Stopcock Manifold w/Rotating Luer. 1 unit per pouch, 50 multivac pouches per case.… |
— |
Identification of a potential manufacturing defect on the internal surface of the NanoClave within specific lots of NanoClave sets, which may inhibit a proper… |
| 2020-07-06 |
Class II
|
Terminated |
Z-0219-2021 |
113" (287 cm) Appx 14.7 ml, 10 Drop Admin Set w/MicroClave" Clear, Remv 4-Way NanoClave" Stopcock, Remv 2-Gang 4-Way Nan… |
— |
Identification of a potential manufacturing defect on the internal surface of the NanoClave within specific lots of NanoClave sets, which may inhibit a proper… |
| 2020-07-06 |
Class II
|
Terminated |
Z-0218-2021 |
126" (320 cm) 16.4 ml, 15 Drop Primary Set w/2 MicroClave Clear, Remv 2 Gang 4-Way NanoClave Stopcock, Rotating Luer, 1 … |
— |
Identification of a potential manufacturing defect on the internal surface of the NanoClave within specific lots of NanoClave sets, which may inhibit a proper… |
| 2020-07-06 |
Class II
|
Terminated |
Z-0217-2021 |
Appx 0.82 ml, 3 Gang 4-Way NanoClave Stopcock w/Baseplate, Rotating Luer; 1 unit per pouch, 50 multivac pouches per case… |
— |
Identification of a potential manufacturing defect on the internal surface of the NanoClave within specific lots of NanoClave sets, which may inhibit a proper… |
| 2020-07-06 |
Class II
|
Terminated |
Z-0216-2021 |
54 IN (137 cm) APPX 7.2 ml EXT SET w NanoClave 4-Way Stopcock ;UDI:(01)10840619082526(17)250201(30)50(10)4718579. Th… |
— |
Identification of a potential manufacturing defect on the internal surface of the NanoClave within specific lots of NanoClave sets, which may inhibit a proper… |
| 2020-07-06 |
Class II
|
Terminated |
Z-0215-2021 |
29 IN (74 cm) APPX 3.9 ml, EXT SET w/ NanoClave 4-Way Stopcock; 1 unit per pouch, 50 pouches per case. UDI:(01)10840619… |
— |
Identification of a potential manufacturing defect on the internal surface of the NanoClave within specific lots of NanoClave sets, which may inhibit a proper… |
| 2020-07-06 |
Class II
|
Terminated |
Z-0214-2021 |
99 IN (251cm) APPX 12.6ml, 20 Drop, 2 Clave, 2 NanoClave 4-Way Stopcocks, Drop-In Ext, Clave; 1 unit per pouch, 25 pouch… |
— |
Identification of a potential manufacturing defect on the internal surface of the NanoClave within specific lots of NanoClave sets, which may inhibit a proper… |
| 2020-07-06 |
Class II
|
Terminated |
Z-0213-2021 |
2 Gang 4-Way NanoClave Stopcock Manifold w/Rotating Luer; 1 unit per pouch, 50 multivac pouches per case. UDI:(01)108877… |
— |
Identification of a potential manufacturing defect on the internal surface of the NanoClave within specific lots of NanoClave sets, which may inhibit a proper… |
| 2020-07-06 |
Class II
|
Terminated |
Z-0212-2021 |
NanoClave Stopcock w/NanoClave; 1 unit per pouch, 50 multivac pouches per case. UDI:(01)10887709062112(17)250101(30)50(1… |
— |
Identification of a potential manufacturing defect on the internal surface of the NanoClave within specific lots of NanoClave sets, which may inhibit a proper… |
| 2020-07-06 |
Class II
|
Terminated |
Z-0211-2021 |
5.5" (14 cm) Appx 0.50 ml, Smallbore Trifuse Ext Set w/3 MicroClave" Clear, NanoClave" T-Connector, 3 Clamps, Rotating L… |
— |
Identification of a potential manufacturing defect on the internal surface of the NanoClave within specific lots of NanoClave sets, which may inhibit a proper… |
| 2020-07-06 |
Class II
|
Terminated |
Z-0210-2021 |
13 IN (33cm) APPX 0.96 ml, PENTAFUSE SMALLBORE SET, NanoClave, 3 MicroClave Clear. 1 unit per pouch, 50 pouches per case… |
— |
Identification of a potential manufacturing defect on the internal surface of the NanoClave within specific lots of NanoClave sets, which may inhibit a proper… |
| 2020-07-06 |
Class II
|
Terminated |
Z-0209-2021 |
9.5" (24 cm) 0.53 ml, Smallbore Bifuse Ext Set w/NanoClave, 3 Clamps, Rotating Luer;1 unit per pouch, 50 multivac pouche… |
— |
Identification of a potential manufacturing defect on the internal surface of the NanoClave within specific lots of NanoClave sets, which may inhibit a proper… |
| 2020-07-06 |
Class II
|
Terminated |
Z-0208-2021 |
12" (30 cm) Appx 0.67 ml, Smallbore Ext Set w/NanoClave, 0.2 Micron Filter, Clamp, Rotating Luer; 1 unit per pouch, 50 m… |
— |
Identification of a potential manufacturing defect on the internal surface of the NanoClave within specific lots of NanoClave sets, which may inhibit a proper… |
| 2020-07-06 |
Class II
|
Terminated |
Z-0207-2021 |
13 IN(33cm) APPX 1.0 ml, SMALLBORE SET, 4 MicroClave Clear, NanoClave T-Conn, Filter; 1 unit per pouch, 50 pouches per c… |
— |
Identification of a potential manufacturing defect on the internal surface of the NanoClave within specific lots of NanoClave sets, which may inhibit a proper… |
| 2020-07-06 |
Class II
|
Terminated |
Z-0206-2021 |
60" (152 cm) Appx 1.0 ml, Smallbore Trifuse Ext Set w/3 MicroClave Clear, NanoClave, 0.2 Micron Filter, 1.2 Micron Filte… |
— |
Identification of a potential manufacturing defect on the internal surface of the NanoClave within specific lots of NanoClave sets, which may inhibit a proper… |
| 2020-07-06 |
Class II
|
Terminated |
Z-0205-2021 |
9.5" (24 cm) Appx 0.56 ml, Smallbore Ext Set w/NanoClave, 0.2 Micron Filter, Clamp, Luer Lock; 1 unit per pouch, 50 mult… |
— |
Identification of a potential manufacturing defect on the internal surface of the NanoClave within specific lots of NanoClave sets, which may inhibit a proper… |
| 2020-07-06 |
Class II
|
Terminated |
Z-0204-2021 |
6.5" (17 cm) Appx 0.35 ml, Smallbore Pressure Infusion (400 psig) Ext Set w/Remv MicroClave Clear, NanoClave, Purple Cla… |
— |
Identification of a potential manufacturing defect on the internal surface of the NanoClave within specific lots of NanoClave sets, which may inhibit a proper… |
| 2020-07-06 |
Class II
|
Terminated |
Z-0203-2021 |
8.5" (22 cm) Appx 0.57 ml, Smallbore Ext Set w/NanoClave, 0.2 Micron Filter, Clamp, Rotating Luer;1 unit per pouch, 50 m… |
— |
Identification of a potential manufacturing defect on the internal surface of the NanoClave within specific lots of NanoClave sets, which may inhibit a proper… |
| 2020-07-06 |
Class II
|
Terminated |
Z-0202-2021 |
8" (20 cm) Appx 0.53 ml, Smallbore Ext Set w/MicroClave Clear, 0.2 Micron Filter, NanoClave T-Connector, Clamp, Rotating… |
— |
Identification of a potential manufacturing defect on the internal surface of the NanoClave within specific lots of NanoClave sets, which may inhibit a proper… |
| 2020-07-06 |
Class II
|
Terminated |
Z-0201-2021 |
7" (18 cm) Appx 0.32 ml, Smallbore Pressure Infusion (400 psig) Ext Set w/Remv MicroClave Clear, NanoClave, Purple Clamp… |
— |
Identification of a potential manufacturing defect on the internal surface of the NanoClave within specific lots of NanoClave sets, which may inhibit a proper… |
| 2020-07-06 |
Class II
|
Terminated |
Z-0200-2021 |
12 IN(30cm) APPX 2.1ml, SMALLBORE HEXAFUSE SET, 6 MicroClave Clear, NanoClave 6 Check Valves;1 unit per pouch, 50 pouche… |
— |
Identification of a potential manufacturing defect on the internal surface of the NanoClave within specific lots of NanoClave sets, which may inhibit a proper… |
| 2020-07-06 |
Class II
|
Terminated |
Z-0199-2021 |
9.5 IN (24cm)APPX 1.1ml SMALLBORE TRIFUSE SET,3 MicroClave CLEAR, NanoClave, 3 CHECK VALVES; 1 unit per pouch, 50 pouche… |
— |
Identification of a potential manufacturing defect on the internal surface of the NanoClave within specific lots of NanoClave sets, which may inhibit a proper… |
| 2020-07-06 |
Class II
|
Terminated |
Z-0198-2021 |
107" (272 cm) Appx 9.1 ml, Smallbore Ext Set w/2 Check Valves, NanoClave T-Connector, Clamp, Rotating Luer; 1 unit per p… |
— |
Identification of a potential manufacturing defect on the internal surface of the NanoClave within specific lots of NanoClave sets, which may inhibit a proper… |
| 2020-07-06 |
Class II
|
Terminated |
Z-0197-2021 |
7" (18 cm) Appx 0.31 ml, Smallbore Pressure Infusion (400psig) Ext Set w/Remv MicroClave Clear, Clamp, NanoClave T-Conne… |
— |
Identification of a potential manufacturing defect on the internal surface of the NanoClave within specific lots of NanoClave sets, which may inhibit a proper… |
| 2020-07-06 |
Class II
|
Terminated |
Z-0196-2021 |
7.5" (19 cm) Appx 0.59 ml, Smallbore Trifuse Ext Set w/3 MicroClave Clear (Yellow, Green, Purple Rings), NanoClave T-Con… |
— |
Identification of a potential manufacturing defect on the internal surface of the NanoClave within specific lots of NanoClave sets, which may inhibit a proper… |
| 2020-07-06 |
Class II
|
Terminated |
Z-0195-2021 |
109" (277 cm) Appx 8.6 ml, Transfer Set w/Check Valve, NanoClave T-Connector, Anti-Siphon Valve, 4 Clamps, Smallbore Tri… |
— |
Identification of a potential manufacturing defect on the internal surface of the NanoClave within specific lots of NanoClave sets, which may inhibit a proper… |
| 2020-07-06 |
Class II
|
Terminated |
Z-0194-2021 |
7" (18 cm) Appx 0.25 ml, Smallbore Ext Set w/Remv NanoClave, Clamp, Luer Lock. 1 unit per pouch, 50 multivac pouches per… |
— |
Identification of a potential manufacturing defect on the internal surface of the NanoClave within specific lots of NanoClave sets, which may inhibit a proper… |
| 2020-07-06 |
Class II
|
Terminated |
Z-0193-2021 |
6.5" (17 cm) Appx 0.30 ml, Smallbore Pressure Infusion (400psig) Ext Set w/Remv MicroClave, NanoClave T-Connector, Purpl… |
— |
Identification of a potential manufacturing defect on the internal surface of the NanoClave within specific lots of NanoClave sets, which may inhibit a proper… |
| 2020-07-06 |
Class II
|
Terminated |
Z-0192-2021 |
9.5" (24 cm) Appx 0.45 ml, Smallbore Pressure Infusion (400 psig) Ext Set w/MicroClave, 2 NanoClave, NanoClave T-Connect… |
— |
Identification of a potential manufacturing defect on the internal surface of the NanoClave within specific lots of NanoClave sets, which may inhibit a proper… |
| 2020-07-06 |
Class II
|
Terminated |
Z-0191-2021 |
5" (13 cm) Appx 0.39 ml, Smallbore Bifuse Ext Set w/NanoClave T-Connector, 2 Clamps, Rotating Luer; 1 unit per pouch, 50… |
— |
Identification of a potential manufacturing defect on the internal surface of the NanoClave within specific lots of NanoClave sets, which may inhibit a proper… |
| 2020-07-06 |
Class II
|
Terminated |
Z-0190-2021 |
9 IN(23 cm) Appx 0.89ml, Smallbore Quadfuse, 4 MicroClave Clear, NanoClave, 0.2 Micron Filter;1 unit per pouch, 50 multi… |
— |
Identification of a potential manufacturing defect on the internal surface of the NanoClave within specific lots of NanoClave sets, which may inhibit a proper… |
| 2020-07-06 |
Class II
|
Terminated |
Z-0189-2021 |
9" (23 cm) Appx 0.63 ml, Smallbore Bifuse Ext Set w/2 MicroClave Clear, NanoClave, 3 Clamps, 0.2 Micron Filter, Rotating… |
— |
Identification of a potential manufacturing defect on the internal surface of the NanoClave within specific lots of NanoClave sets, which may inhibit a proper… |
| 2020-07-06 |
Class II
|
Terminated |
Z-0188-2021 |
10" (25 cm) Appx 2.8 ml, Trifuse Ext Set w/3 MicroClave¿ Clear, Tri-Connector, NanoClave¿ T-Connector, 4 Clamps (Red, Wh… |
— |
Identification of a potential manufacturing defect on the internal surface of the NanoClave within specific lots of NanoClave sets, which may inhibit a proper… |
| 2020-07-06 |
Class II
|
Terminated |
Z-0187-2021 |
7" (18cm) Appx 0.31 ml, Smallbore Ext Set w/Remv MicroClave¿ Clear, NanoClave T-Connector, Clamp, Rotating Luer. 1 unit … |
— |
Identification of a potential manufacturing defect on the internal surface of the NanoClave within specific lots of NanoClave sets, which may inhibit a proper… |
| 2020-07-06 |
Class II
|
Terminated |
Z-0186-2021 |
7" (18 cm) Appx 0.29 ml, Smallbore Ext Set w/MicroClave Clear, NanoClave, Clamp, Rotating Luer; 1 unit per pouch, 50 mul… |
— |
Identification of a potential manufacturing defect on the internal surface of the NanoClave within specific lots of NanoClave sets, which may inhibit a proper… |
| 2020-07-06 |
Class II
|
Terminated |
Z-0185-2021 |
5 IN(13cm) APPX 0.87ml, EXT SET,NanoClave T-CONNECTOR; 1 unit per pouch, 50 pouches per case; UDI: (01)10887709052809(1… |
— |
Identification of a potential manufacturing defect on the internal surface of the NanoClave within specific lots of NanoClave sets, which may inhibit a proper… |
| 2020-07-06 |
Class II
|
Terminated |
Z-0184-2021 |
6" (15 cm) Appx 0.24 ml, Smallbore Ext Set w/MicroClave Clear, Clamp, NanoClave T-Connector, Rotating Luer; 1 unit per p… |
— |
Identification of a potential manufacturing defect on the internal surface of the NanoClave within specific lots of NanoClave sets, which may inhibit a proper… |
| 2020-07-06 |
Class II
|
Terminated |
Z-0183-2021 |
6" (15 cm) Appx 0.26 ml, Smallbore Ext Set w/Clamp, NanoClave T-Connector, Rotating Luer; 1 unit per pouch, 50 multivac … |
— |
Identification of a potential manufacturing defect on the internal surface of the NanoClave within specific lots of NanoClave sets, which may inhibit a proper… |
| 2020-07-06 |
Class II
|
Terminated |
Z-0182-2021 |
NanoClave Connector; 1 unit per pouch, 100 multivac pouches per case;UDI (01)10887709051017(17)241201(30)100(10)4549051;… |
— |
Identification of a potential manufacturing defect on the internal surface of the NanoClave within specific lots of NanoClave sets, which may inhibit a proper… |
| 2020-07-01 |
Class II
|
Terminated |
Z-0511-2021 |
REF MC330209 6' (15 cm) Appx 0.09 ml, Smallbore Trifuse Ext Set w/3 MicroClave Clear, 0.2 Micron Filter, 1.2 Micron Filt… |
— |
Incorrect filter assemblies in IV administration set. |
| 2020-02-14 |
Class II
|
Terminated |
Z-1927-2020 |
The Cogent Hemodynamic Monitoring System. REF58400-000, GTIN 00840619099459; REF 58400-000R, GTIN 0087709094314; REF 584… |
— |
Firm identified software issues which leads to the patient ID and patient information not being stored in the system. |
| 2020-01-02 |
Class II
|
Terminated |
Z-2002-2020 |
Central Venous Catheters are indicated for the assessment of hemodynamic status through right atrial, right ventricular,… |
— |
Inability for the guidewire to pass through the needles included with the catheter kits. |
| 2020-01-02 |
Class II
|
Terminated |
Z-2001-2020 |
Central Venous Catheters are indicated for the assessment of hemodynamic status through right atrial, right ventricular,… |
— |
Inability for the guidewire to pass through the needles included with the catheter kits. |
| 2020-01-02 |
Class II
|
Terminated |
Z-2000-2020 |
Central Venous Catheters are indicated for the assessment of hemodynamic status through right atrial, right ventricular,… |
— |
Inability for the guidewire to pass through the needles included with the catheter kits. |
| 2020-01-02 |
Class II
|
Terminated |
Z-1999-2020 |
Central Venous Catheters are indicated for the assessment of hemodynamic status through right atrial, right ventricular,… |
— |
Inability for the guidewire to pass through the needles included with the catheter kits. |
| 2020-01-02 |
Class II
|
Terminated |
Z-1998-2020 |
Central Venous Catheters are indicated for the assessment of hemodynamic status through right atrial, right ventricular,… |
— |
Inability for the guidewire to pass through the needles included with the catheter kits. |
| 2020-01-02 |
Class II
|
Terminated |
Z-1997-2020 |
Central Venous Catheters are indicated for the assessment of hemodynamic status through right atrial, right ventricular,… |
— |
Inability for the guidewire to pass through the needles included with the catheter kits. |
| 2020-01-02 |
Class II
|
Terminated |
Z-1996-2020 |
Central Venous Catheters are indicated for the assessment of hemodynamic status through right atrial, right ventricular,… |
— |
Inability for the guidewire to pass through the needles included with the catheter kits. |