BEUDAMED
    FDA Recall Terminated

    Acticoat* Moisture Control Dressing, Product Code 20211, Distributed by Smith & Nephew, Inc., Wound Management Division, 11775 Starkey Road, Largo, FL 33773

    Recall: Z-0016-04 · Initiated April 15, 2003

    Recall

    Recall Number
    Z-0016-04
    Event Number
    26318
    Firm
    Smith And Nephew, Inc. Wound Management Division
    FEI Number
    3006760724
    Status
    Terminated
    Root Cause
    Other
    Initiated
    April 15, 2003
    Posted
    October 15, 2003
    Terminated
    July 11, 2012
    Address
    11775 Starkey Rd, Largo, FL, 33773

    Description

    Acticoat* Moisture Control Dressing, Product Code 20211, Distributed by Smith & Nephew, Inc., Wound Management Division, 11775 Starkey Road, Largo, FL 33773

    Reason

    Product may not meet the established stability specification before the end of labeled expiry date.

    Action

    A Recall notification with a Response Form was mailed first class with return reciept requested on April 15, 2003 to direct accounts. The recall was to the wholesale distributor level only. The accounts were asked to check their stock immediately and to return recalled product to the Recalling Firm in Largo, FL. Non responding accounts were sent follow-up Recall Notifications letters.

    Distribution

    The recalled devices were distributed to 81 direct wholesalers or medical facilities nationwide. There were no direct international or government/military accounts.

    Quantity

    3355