PowerLoc MAX Power Injectable Infusion Set with GuardIVa Antimicrobial Hemostatic Dressing Port Access Kit; Catalog Numbers 2132010G (UDI 00801741095504), 2132015G (UDI 00801741095511), 2141910G (UDI ...
Reason: Potential development of cracks or breaks in the tubing near the Luer or Y site of the device. Devices that have developed breaks or cracks can cause leakage resulting in exposure ...
Reason: Potential development of cracks or breaks in the tubing near the Luer or Y site of the device. Devices that have developed breaks or cracks can cause leakage resulting in exposure ...
Z-2671-2020July 29, 2020Franklin Lakes, NJ
Becton Dickinson & Company
Class IITerminated
SafeStep Huber Needle Set with Y Injection Site and Medegen Needleless Injection Cap; Catalog Numbers LH-0029YN (UDI 00801741066177), LH-0030YN (UDI 00801741066191), LH-0031YN (UDI 00801741066214), LH...
Reason: Potential development of cracks or breaks in the tubing near the Luer or Y site of the device. Devices that have developed breaks or cracks can cause leakage resulting in exposure ...
Z-2669-2020July 29, 2020Franklin Lakes, NJ
Carefusion 2200 Inc
Class IITerminated
Safe-T-Centesis PLUS 6 Fr Catheter Drainage Tray
Reason: The Universal Drainage Set (UDS) may contain valves that leak internally which may result in the introduction of up to 30cc of air into the patient.
Z-2650-2020July 29, 2020Vernon Hills, IL
Carefusion 2200 Inc
Class IITerminated
Thora-Para 5 Fr Catheter Drainage Tray
Reason: The Universal Drainage Set (UDS) may contain valves that leak internally which may result in the introduction of up to 30cc of air into the patient.
Z-2657-2020July 29, 2020Vernon Hills, IL
Becton Dickinson & Company
Class IITerminated
SafeStep Huber Needle Set with GuardIVa Antimicrobial Hemostatic Dressing Port Access Kit; Catalog Numbers PA-0031G (UDI 00801741085666), PA-0031YNG (UDI 00801741085673), PA-0032G (UDI 00801741087639)...
Reason: Potential development of cracks or breaks in the tubing near the Luer or Y site of the device. Devices that have developed breaks or cracks can cause leakage resulting in exposure ...
Z-2668-2020July 29, 2020Franklin Lakes, NJ
Carefusion 2200 Inc
Class IITerminated
Safe-T 5 Fr Thora-Para Tray With 5 Fr. Catheter and Sharps Injury Protection - Drug Free
Reason: The Universal Drainage Set (UDS) may contain valves that leak internally which may result in the introduction of up to 30cc of air into the patient.
Z-2658-2020July 29, 2020Vernon Hills, IL
Carefusion 2200 Inc
Class IITerminated
Safe-T-Centesis PLUS 8 Fr Catheter Drainage Tray
Reason: The Universal Drainage Set (UDS) may contain valves that leak internally which may result in the introduction of up to 30cc of air into the patient.
Reason: The Universal Drainage Set (UDS) may contain valves that leak internally which may result in the introduction of up to 30cc of air into the patient.
Z-2654-2020July 29, 2020Vernon Hills, IL
Carefusion 2200 Inc
Class IITerminated
Thora-Para 8 Fr Catheter Drainage Tray
Reason: The Universal Drainage Set (UDS) may contain valves that leak internally which may result in the introduction of up to 30cc of air into the patient.
Reason: Potential development of cracks or breaks in the tubing near the Luer or Y site of the device. Devices that have developed breaks or cracks can cause leakage resulting in exposure ...
Z-2666-2020July 29, 2020Franklin Lakes, NJ
Becton Dickinson & Company
Class IITerminated
PowerLoc MAX Power Injectable Infusion Set AllPoints Port Access System; Catalog Numbers AN132075 (UDI 00801741118968), AN142010 (UDI 00801741119231), AN142010G (UDI 00801741119323), AN142075 (UDI 008...
Reason: Potential development of cracks or breaks in the tubing near the Luer or Y site of the device. Devices that have developed breaks or cracks can cause leakage resulting in exposure ...
Z-2660-2020July 29, 2020Franklin Lakes, NJ
Becton Dickinson & Company
Class IITerminated
PowerLoc MAX Power-Injectable Infusion Set myPICK Port Access Kit; Catalog Numbers CPA00001 (UDI 00801741098345), CPA00002 (UDI 00801741098352), CPA00028 (UDI 00801741129728), CPA00032 (UDI 0080174113...
Reason: Potential development of cracks or breaks in the tubing near the Luer or Y site of the device. Devices that have developed breaks or cracks can cause leakage resulting in exposure ...
Reason: Potential development of cracks or breaks in the tubing near the Luer or Y site of the device. Devices that have developed breaks or cracks can cause leakage resulting in exposure ...
Reason: Potential development of cracks or breaks in the tubing near the Luer or Y site of the device. Devices that have developed breaks or cracks can cause leakage resulting in exposure ...
Z-2670-2020July 29, 2020Franklin Lakes, NJ
Carefusion 2200 Inc
Class IITerminated
Safe-T PLUS Thora-Para 8 Fr Catheter Drainage Tray
Reason: The Universal Drainage Set (UDS) may contain valves that leak internally which may result in the introduction of up to 30cc of air into the patient.
Reason: The Universal Drainage Set (UDS) may contain valves that leak internally which may result in the introduction of up to 30cc of air into the patient.
Reason: Wellspect Healthcare is voluntarily recalling certain LoFric¿ Origo" urethral catheters due to a potential defect which may be present in the catheters distal tip.
Z-2645-2020July 29, 2020Molndal, N/A
Becton Dickinson & Company
Class IITerminated
SafeStep Huber Needle Set myPICK Port Access Kit; Catalog Numbers CPA00020A (UDI 00801741129827), CPA00042A (UDI 00801741182969), CPA00049 (UDI 00801741175695)
Reason: Potential development of cracks or breaks in the tubing near the Luer or Y site of the device. Devices that have developed breaks or cracks can cause leakage resulting in exposure ...
Z-2665-2020July 29, 2020Franklin Lakes, NJ
Carefusion 2200 Inc
Class IITerminated
Safe-T PLUS Thora-Para 5 Fr Catheter Drainage Tray
Reason: The Universal Drainage Set (UDS) may contain valves that leak internally which may result in the introduction of up to 30cc of air into the patient.
Z-2659-2020July 29, 2020Vernon Hills, IL
Carefusion 2200 Inc
Class IITerminated
Safe-T 8 Fr Thora-Para Tray With 8 Fr. Catheter and Sharps Injury Protection - Drug Free
Reason: The Universal Drainage Set (UDS) may contain valves that leak internally which may result in the introduction of up to 30cc of air into the patient.
Z-2655-2020July 29, 2020Vernon Hills, IL
Access Scientific LLC
Class IIITerminated
POWERWAND XL 4Fr 8cm Maximum Barrier Kit (Introducer with an Extended Dwell Catheter made of ChronoFlex C with BioGUARD Technology), Catalog No. 94108, Device UDI 00859821006773/Pacakge UDI 1085982100...
Reason: Convenience kit mislabeled with the incorrect catheter effective length on the device label and the packaging label. Use may lead to a delay or interruption of treatment and user d...
Z-2550-2020July 22, 2020San Diego, CA
Prodimed Plastimed Division
Class IITerminated
Prodimed Combicath Paediatric catheters for blind protected distal bronchial sampling-" COMBICATH PE 35 cm Product Code: 58 223 19
Reason: Lack of assurance of sterility
Z-2492-2020July 15, 2020Le Plessis Bouchard
Prodimed Plastimed Division
Class IITerminated
Prodimed Combicath catheters for mini bronchoalveolar lavage (BAL)-COMBICATH PE 85 cm x 4.0 mm 58124 40US
Reason: Lack of assurance of sterility
Z-2488-2020July 15, 2020Le Plessis Bouchard
Ra Medical Systems, Inc.
Class IITerminated
DABRA Laser (RA-308 Excimer Laser). The DABRA Laser and DABRA Catheter is an excimer laser ultraviolet light source and delivery system, collectively the DABRA Laser System". The system is designed to...
Reason: A software issue was identified which could result in user or patient injury, or may adversely impact laser performance. It is possible that an unintended release of laser light (r...