BEUDAMED
    FDA Enforcement Class II Terminated

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

    Recall: Z-1705-2017 · Reported April 12, 2017

    Enforcement

    Recall Number
    Z-1705-2017
    Event ID
    76637
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Arrow International Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    April 12, 2017
    Initiation Date
    March 3, 2017
    Classification Date
    April 3, 2017
    Termination Date
    February 27, 2018
    Address
    2400 Bernville Rd, N/A, Reading, PA, 19605-9607, United States

    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.

    Code Info

    Device Listing Number: D149129 Lot Numbers: 23F16C0851, 23F16A0727 and 23F16C0844

    Distribution

    US Distribution

    Quantity

    1,351 catheters