BEUDAMED
    FDA Recall Terminated

    V.A.C. X-Large Granufoam Dressing Part Numbers M6275065/5, V.A.C. ATS and V.A.C. Freedom and M6275043/5 V.A.C. Classic. Manufactured by Kinetic Concepts, Inc., San Antonio, Texas 78230

    Recall: Z-0038-05 · Initiated September 21, 2004

    Recall

    Recall Number
    Z-0038-05
    Event Number
    30212
    Firm
    Kinetic Concepts, Inc
    FEI Number
    1625774
    Product Code
    JCX
    Status
    Terminated
    Root Cause
    Other
    Initiated
    September 21, 2004
    Posted
    October 22, 2004
    Terminated
    June 7, 2005
    Address
    4958 Stout Dr, San Antonio, TX, 78219-4334

    Description

    V.A.C. X-Large Granufoam Dressing Part Numbers M6275065/5, V.A.C. ATS and V.A.C. Freedom and M6275043/5 V.A.C. Classic. Manufactured by Kinetic Concepts, Inc., San Antonio, Texas 78230

    Reason

    The seal on the dressing pouch may open during shipping and sterility of the dressing may be compromised.

    Action

    The firm initiated the recall by letter and phone calls on September 21, 2004.

    Distribution

    The product was distributed to hospitals and clinics nationwide. The product was also shipped to the following foreign countries: Australia, Austria, Belgium, Canada, Denmark, France, Germany, Greece, Qatar, Phillipines, United Arab Emirates, Ireland, Italy, Netherlands, South Africa, Spain, Sweden, Switzerland, and United Kingdom.

    Quantity

    29610 units