BEUDAMED
    FDA Recall Terminated

    GuardIVa Antimicrobial Hemostatic IV Dressing, REF FP-23-AD008, Manufacturer: Bard Access Systems, Inc. USA. Product Code FP23AD006.

    Recall: Z-0493-2015 · Initiated November 3, 2014

    Recall

    Recall Number
    Z-0493-2015
    Event Number
    69683
    Firm
    Bard Access Systems
    FEI Number
    3006260740
    Product Code
    FRO
    Status
    Terminated
    Root Cause
    Mixed-up of materials/components
    Initiated
    November 3, 2014
    Posted
    December 1, 2014
    Terminated
    May 12, 2015
    Address
    605 North 5600, West Salt Lake City, UT, 84116-3738

    Description

    GuardIVa Antimicrobial Hemostatic IV Dressing, REF FP-23-AD008, Manufacturer: Bard Access Systems, Inc. USA. Product Code FP23AD006.

    Reason

    Bard Access Systems is recalling GuardIVa (Ref. No. FP23AD006) from lot ASXHT003 because they were non-sterile unit samples which potentially could be used clinically.

    Action

    A customer letter was sent on 11/3/14 requesting immediate examination of inventory and to quarantine the products for return.

    Distribution

    US Distribution to state of: TX, OK, LA, and AR.

    Quantity

    2532 units