BEUDAMED
    FDA Recall Terminated

    Multidex Powder, Maltodextrin Wound Dressing, Catalog Numbers: 46-701, 46-702, 46-703, 46-704, 46-702-1, 46-703-1, 46-704-1; Type of Packaging: Tubes, dispenser box

    Recall: Z-0544-04 · Initiated January 19, 2004

    Recall

    Recall Number
    Z-0544-04
    Event Number
    28270
    Firm
    DeRoyal Surgical Tray
    FEI Number
    3003040625
    Product Code
    NAC
    Status
    Terminated
    Root Cause
    Other
    Initiated
    January 19, 2004
    Posted
    February 24, 2004
    Terminated
    October 13, 2004
    Address
    1595 Highway 33 S, New Tazewell, TN, 37825-7105

    Description

    Multidex Powder, Maltodextrin Wound Dressing, Catalog Numbers: 46-701, 46-702, 46-703, 46-704, 46-702-1, 46-703-1, 46-704-1; Type of Packaging: Tubes, dispenser box

    Reason

    Hydrophilic powder wound dressing, sterilized at a dosage which subsequently failed a sterility audit, was distributed.

    Action

    The firm notified their consignees via letter sent UPS 2nd day air on 01/19/2004 requesting return of the product.

    Distribution

    Nationwide and Europe

    Quantity

    2,495 units