Recall Z-1705-2017 ยท LJS Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days
Arrow International Inc
The CG+ Arrow PIC Catheters permit venous access to the central circulation through a peripheral vein.
| Date | Mar 8, 2017 (initiated Mar 3, 2017) |
| Status | Terminated |
| 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. |
| Root cause | Under Investigation by firm |
| Action | Arrow International mailed an Urgent Medical Device Recall Notification letter to affected customers on March 7, 2017, to inform them of the issue. The notification informs customers to discontinue use and quarantine any products identified with the specific lot numbers. Customers are asked to complete the enclosed Recall Acknowledgement Form for product return. For further questions, please call (866) 246-6990. |
| Quantity | 1,351 catheters |
| Distribution | US Distribution |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K112896 | ARRW EVOLUTION Arrow International (Subsidiary of Teleflex Inc.), May 10, 2012 |