BEUDAMED
    FDA Enforcement Class II 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 · Reported October 22, 2014

    Enforcement

    Recall Number
    Z-0070-2015
    Event ID
    69368
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    KCI USA, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    October 22, 2014
    Initiation Date
    September 18, 2014
    Classification Date
    October 15, 2014
    Termination Date
    July 24, 2015
    Address
    6203 Farinon Dr, N/A, San Antonio, TX, 78249-3441, United States

    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.

    Code Info

    Lot Number 50775911

    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)