BEUDAMED
    FDA Recall Terminated

    LIGACLIP ERCA Endoscopic Rotating Multiple Clip Applier (Product Code: ER320) and assorted Flex Trays(Convenience Kits), containing ER320, LIGACLIP ERCA Endoscopic Rotating Multiple Clip Appliers.

    Recall: Z-1055-04 · Initiated June 7, 2004

    Recall

    Recall Number
    Z-1055-04
    Event Number
    29269
    Firm
    Ethicon Endo-Surgery
    FEI Number
    1527736
    Product Code
    GDO
    Status
    Terminated
    Root Cause
    Other
    Initiated
    June 7, 2004
    Posted
    July 20, 2004
    Terminated
    October 29, 2008
    Address
    4545 Creek Rd, Cincinnati, OH, 45242-2803

    Description

    LIGACLIP ERCA Endoscopic Rotating Multiple Clip Applier (Product Code: ER320) and assorted Flex Trays(Convenience Kits), containing ER320, LIGACLIP ERCA Endoscopic Rotating Multiple Clip Appliers.

    Reason

    This device is subject to recall due to an increased possibility of clip scissoring which can result in less than optimal clip formation which may or may not securely ligate tubular structures.

    Action

    The firm contacted their customers via letter on June 7, 2004. The suspect product and Flex Tray kits will be returned and destroyed.

    Distribution

    The product was shipped to hospitals and distributors nationwide and worldwide.

    Quantity

    120,4015