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Terminated

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

FDA Recall Z-1705-2017 · Posted 2017-03-08

Recalling FirmArrow International Inc
Recall StatusTerminated
Product CodeLJS
Date Initiated2017-03-03
Date Terminated2018-02-27
Product Quantity1,351 catheters

Reason for Recall

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.

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.

Root Cause

Under Investigation by firm

Distribution Pattern

US Distribution

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K112896ARRW EVOLUTIONArrow International (Subsidiary of Teleflex Inc.) · 2012-05-10

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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