BEUDAMED
    FDA Recall Terminated

    Stockinette, Double Ply, Econo Weave, 6 X 54'', 6 X 60'', 6 X 72'', 8 X 48'', 8 X 72'', Ref #9984-54, #9984-54, #9985-60, #9986-72, #9987-48, #9988-60, #9988-72

    Recall: Z-1494-04 · Initiated September 9, 2004

    Recall

    Recall Number
    Z-1494-04
    Event Number
    30045
    FEI Number
    1046367
    Product Code
    KKX
    Status
    Terminated
    Root Cause
    Other
    Initiated
    September 9, 2004
    Posted
    September 29, 2004
    Terminated
    May 16, 2005
    Address
    Deroyal Surgical Rose Hill 100 Rose Hill Industrial Park, Rose Hill, VA, 24281

    Description

    Stockinette, Double Ply, Econo Weave, 6 X 54'', 6 X 60'', 6 X 72'', 8 X 48'', 8 X 72'', Ref #9984-54, #9984-54, #9985-60, #9986-72, #9987-48, #9988-60, #9988-72

    Reason

    Surgical drapes and covers were packaged in containers with incomplete seals which compromise product sterility.

    Action

    The recalling firm ceased distribution of Stockinette products on 8/26/04 and subsequently notified distributors and direct accounts by letter 9/9/04. The notification was product and lot specific and advised consignees of compromised sterility. Consignees were advised to return response form and product for credit. Distributors were asked to forward the recall notice and respond with a consignee list if they had not notified their accounts. Sub accounts and end users were notified by letter 9/20/04.

    Distribution

    Product was sold to distributors and direct accounts nationwide and to distributors in Ireland, Peru and Israel.

    Quantity

    395 cases