BEUDAMED
    FDA Recall Terminated

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

    Recall: Z-1705-2017 · Initiated March 3, 2017

    Recall

    Recall Number
    Z-1705-2017
    Event Number
    76637
    Firm
    Arrow International Inc
    FEI Number
    3015859709
    Product Code
    LJS
    Status
    Terminated
    Root Cause
    Under Investigation by firm
    Initiated
    March 3, 2017
    Posted
    March 8, 2017
    Terminated
    February 27, 2018
    Address
    2400 Bernville Rd, Reading, PA, 19605-9607

    Description

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

    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.

    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.

    Distribution

    US Distribution

    Quantity

    1,351 catheters