Device product
The CG+ Arrow PIC Catheters permit venous access to the central circulation through a peripheral vein.
Z-1705-2017
Product summary
- Event
- Event 76637
- Status
- Terminated
- Classification
- Class II
- Quantity
- 1,351 catheters
- Official record key
device-enforcement:Z-1705-2017
Official wording
Reason: Arrow International, Inc. notified its customers who received the affected Antimicrobial/Antithrombogenic PICC Kits, that the kits were being recalled due to a labeling error. The lidstock on some of the kits reads CDC-45541-HPK1A, while the banner card on the side of the kit reads CDC-45052-HPK1A. Other kits may list CDC-45052-HPK1A on the lidstock and CDC-45541-HPK1A on the banner card. The affected lot numbers are 23F16C0851, 23F16A0727, and 23F16C0844.
Code information: Device Listing Number: D149129 Lot Numbers: 23F16C0851, 23F16A0727 and 23F16C0844
Distribution pattern: US Distribution
Derived failure modes
-
Labeling or packaging
labeling error