BEUDAMED
    FDA Recall Terminated

    V.A.C. GranuFoam Silver Large Dressing is barrier to bacterial penetration and may help reduce infection. Featuring SensaT.R.A.C. Technology REF M8275099/10 STERILE Single Use only Latex Free Rx Only.

    Recall: Z-0070-2015 · Initiated September 18, 2014

    Recall

    Recall Number
    Z-0070-2015
    Event Number
    69368
    Firm
    KCI USA, Inc.
    FEI Number
    3005178245
    Product Code
    OMP
    Status
    Terminated
    Root Cause
    Error in labeling
    Initiated
    September 18, 2014
    Posted
    October 15, 2014
    Terminated
    July 24, 2015
    Address
    6203 Farinon Dr, San Antonio, TX, 78249-3441

    Description

    V.A.C. GranuFoam Silver Large Dressing is barrier to bacterial penetration and may help reduce infection. Featuring SensaT.R.A.C. Technology REF M8275099/10 STERILE Single Use only Latex Free Rx Only.

    Reason

    A portion of the V.A.C. GranuFoam Silver Dressing M8275099/10 lot 50775977 was incorrectly manufactured with an incorrect expiry date on the sterile pouch. The correct expiry date of 2015-11 is on the case label, however the pouch label identifies the expiry date of 2016-11.

    Action

    KCI will send a customer letter to each consignee notifying them of the issue, and to return the affected units.

    Distribution

    The affected product was distributed to Mexico, Turkey, and United Arab Emirates only. The affected product was not distributed to the US.

    Quantity

    1090 pouches (109 boxes)