BEUDAMED
    FDA Recall Terminated

    Adept-Med brand Glassman Viscera Retainer FISH Sterile, Item Numbers: 3204, 3202, 3203, 3202, 3201, 3200, 3206; Product is manufactured and distributed by Adept-Med International, Inc., 665 Pleasant Valley Rd., Diamond Springs, CA 95619

    Recall: Z-1156-06 · Initiated August 17, 2004

    Recall

    Recall Number
    Z-1156-06
    Event Number
    35406
    Firm
    Adept-Med International Inc
    FEI Number
    3000718212
    Product Code
    GZC
    Status
    Terminated
    Root Cause
    Other
    Initiated
    August 17, 2004
    Posted
    June 22, 2006
    Terminated
    December 28, 2006
    Address
    694 Pleasant Valley Rd, Ste 4, Diamond Springs, CA, 95619-9249

    Description

    Adept-Med brand Glassman Viscera Retainer FISH Sterile, Item Numbers: 3204, 3202, 3203, 3202, 3201, 3200, 3206; Product is manufactured and distributed by Adept-Med International, Inc., 665 Pleasant Valley Rd., Diamond Springs, CA 95619

    Reason

    Devices for which sterility may be compromised as evidenced by a loss of package integrity.

    Action

    On 8/13/04, the firm initiated the recall and its notification was via letters explaining the reason for the recall and requesting the product be returned.

    Distribution

    Nationwide-The product was released for distribution to 249 consignees in US. The firm identified 242 hospitals and 7 distributors. The recall was appropriately extended to the consumer/user level; i.e., the wholesalers/distributors, pharmacists, hospitals who received the recalled product.

    Quantity

    7,600 units