BEUDAMED
    FDA Recall Terminated

    PTFE (Polytetrafluoroethylene) felt. Catalog #s: M002000193041, M002000193061, M002000193811, M002000193821, M002000193931, M002000193841, M002000193861, M002000193881.

    Recall: Z-0931-05 · Initiated April 19, 2005

    Recall

    Recall Number
    Z-0931-05
    Event Number
    31998
    Firm
    Boston Scientific Scimed
    FEI Number
    3002095335
    Product Code
    DXZ
    Status
    Terminated
    Root Cause
    Other
    Initiated
    April 19, 2005
    Posted
    June 25, 2005
    Terminated
    October 3, 2006
    Address
    1 Scimed Pl, Maple Grove, MN, 55311-1565

    Description

    PTFE (Polytetrafluoroethylene) felt. Catalog #s: M002000193041, M002000193061, M002000193811, M002000193821, M002000193931, M002000193841, M002000193861, M002000193881.

    Reason

    Units of these lots may have areas of lower density resulting in lower tensile and suture retention strength.

    Action

    Recall letters letters were sent to all customers on 4/19/2005 with instructions to discontinue using the identified felt products.

    Distribution

    The product was distributed to hospitals nationwide.

    Quantity

    290 packs containing 5 pieces of Felt.