BEUDAMED
    FDA Enforcement Class II Terminated

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

    Recall: Z-0493-2015 · Reported December 10, 2014

    Enforcement

    Recall Number
    Z-0493-2015
    Event ID
    69683
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Bard Access Systems
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    December 10, 2014
    Initiation Date
    November 3, 2014
    Classification Date
    December 1, 2014
    Termination Date
    May 12, 2015
    Address
    605 North 5600 West, N/A, Salt Lake City, UT, 84116-3738, United States

    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.

    Code Info

    Product Code FP23AD006, Lot No.ASXHT003, Expiration Date Feb 2016

    Distribution

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

    Quantity

    2532 units