BEUDAMED
    FDA Recall Terminated

    Arrow Select Kits (ASK), Maximal Barrier Precautions Kits (CDC) and Arterial Catheterization Kit (NA) with Biopatch Dressing

    Recall: Z-1030-2015 · Initiated January 9, 2015

    Recall

    Recall Number
    Z-1030-2015
    Event Number
    70313
    Firm
    Arrow International Inc
    FEI Number
    3015859709
    Product Code
    OBJ
    Status
    Terminated
    Root Cause
    Packaging process control
    Initiated
    January 9, 2015
    Posted
    January 29, 2015
    Terminated
    August 23, 2017
    Address
    2400 Bernville Road, Reading, PA, 19605

    Description

    Arrow Select Kits (ASK), Maximal Barrier Precautions Kits (CDC) and Arterial Catheterization Kit (NA) with Biopatch Dressing

    Reason

    Certain product codes and lot numbers of Kits with Biopatch Dressing were packaged with the incorrect size Biopatch Dressing. No risk to patients is anticipated.

    Action

    Arrow International, Inc. (Arrow) sent notification letters, dated January 9, 2015, to alert their direct account customers that it may be necessary to obtain an alternate Biopatch Dressing if a kit is used that contains an incorrectly sized Biopatch Dressing. Due to the inconvenience, Arrow will reimburse customers $7.50 per kit received.

    Distribution

    US (nationwide) and PR.

    Quantity

    4484