—#153712

Product

The CG+ Arrow PIC Catheters permit venous access to the central circulation through a peripheral vein.

FDA product code: LJS — Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days
Device class: Class 2
Medical specialty: General Hospital
510(k) numbers: K112896
Affected lot / code info: Device Listing Number: D149129 Lot Numbers: 23F16C0851, 23F16A0727 and 23F16C0844

Why it was recalled

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 (FDA determination)

Under Investigation by firm

Action the firm took

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.

Recalling firm

Firm: Arrow International Inc
Address: 2400 Bernville Rd, Reading, Pennsylvania 19605-9607

Distribution

Distribution pattern: US Distribution

Timeline

Recall initiated: 2017-03-03
Posted by FDA: 2017-03-08
Terminated: 2018-02-27
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #153712. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.