CARTO 3 System (Software Version V7.1.80), CARTO VISITAG Module - Product Usage: FGThe intended use of the system is catheter-based cardiac electrophysiological (EP) procedures. The system provides in...
Reason: Software defect may result in disapperance of tag sites during recalculation and lead to additional ablation sites. This may lead to prolongation of the procedure and, in extremely...
ClosureFast Micro Introducer Sheath Set, REF MIS-7F11; 7Fr/Ch (2.3mm)x11 cm. STERILE|EO; Rx ONLY - Product Usage: Introducer Products are stand-alone components, standard kits, or convenience kits bui...
Reason: Sterile introducer sheath set manufactured under one lot with different expiration dates.
Z-2806-2020August 26, 2020Athens, TX
Arrow International Inc
Class IITerminated
Arrow TheraCath Epidural Catheter - Product Usage: The Arrow Epidural Catheter permits access to the epidural space.
Reason: The lidstock states the incorrect expiration date for the product. This issue could result in use of a device that is expired which could potentially lead to an increased risk of i...
Z-2803-2020August 19, 2020Reading, PA
Medline Industries Inc
Class IIOngoing
ClearPro Trach T-Piece Closed Suction Catheter, Model DYNCPTP14T, 14 Fr 12.5 IN FOR TRACHEOSTOMY TUBE - Product Usage: Catheters are intended for endotracheal suction of adult patients with artificial...
Reason: There are reports of the suction catheter coming apart from the device assembly during use.
Z-2725-2020August 5, 2020Northfield, IL
Medline Industries Inc
Class IIOngoing
ClearPro T-Piece Closed Suction Catheter, Model DYNCPTP14, 14 Fr 21.3 IN FOR ENDOTRACHEAL TUBE - Product Usage: Catheters are intended for endotracheal suction of adult patients with artificial airway...
Reason: There are reports of the suction catheter coming apart from the device assembly during use.
Z-2724-2020August 5, 2020Northfield, IL
Becton Dickinson & Company
Class IITerminated
PowerLoc MAX Power Injectable Infusion Port Access Kit; Catalog Numbers 2131910 (UDI 00801741044151), 2131915 (UDI 00801741044168), 2131975 (UDI 00801741044175), 2132010 (UDI 00801741044151), 2132015 ...
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: Wellspect Healthcare is voluntarily recalling certain LoFric¿ Origo" urethral catheters due to a potential defect which may be present in the catheter s distal tip.
Z-2643-2020July 29, 2020Molndal, N/A
Carefusion 2200 Inc
Class IITerminated
Safe-T-Centesis 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.
Z-2651-2020July 29, 2020Vernon Hills, IL
Carefusion 2200 Inc
Class IITerminated
Safe-T-Centesis 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-2648-2020July 29, 2020Vernon Hills, IL
Carefusion 2200 Inc
Class IITerminated
Thora-Para 5 Fr Non-Valved 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-2646-2020July 29, 2020Vernon Hills, IL
Becton Dickinson & Company
Class IITerminated
SafeStep Huber Needle Set with GuardIVa Antimicrobial Hemostatic Dressing; Catalog Number CPA00040 (UDI 00801741143892)
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: 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-2644-2020July 29, 2020Molndal, N/A
Carefusion 2200 Inc
Class IITerminated
Safe-T PLUS Thora-Para 5 Fr Non-Valved 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.