BEUDAMED
    FDA Recall Terminated

    Boston Scientific Radial Jaw Large Capacity Biopsy Forceps with Needle, Sterile, 240 mm. Box of 20 UPN Number: M00513331 REF: 1333-20

    Recall: Z-0117-2008 · Initiated August 28, 2007

    Recall

    Recall Number
    Z-0117-2008
    Event Number
    44736
    Firm
    Boston Scientific Corporation
    FEI Number
    3005099803
    Product Code
    FFF
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    August 28, 2007
    Posted
    October 31, 2007
    Terminated
    July 10, 2008
    Address
    100 Boston Scientific Way, Marlborough, MA, 01752-1234

    Description

    Boston Scientific Radial Jaw Large Capacity Biopsy Forceps with Needle, Sterile, 240 mm. Box of 20 UPN Number: M00513331 REF: 1333-20

    Reason

    Device lacked manufacturing finishing process resulting in endoscope damage.

    Action

    Boston Scientific notified accounts by letter on 8/28/07 by Federal Express Priority mail. Accounts are requested to remove product from inventory and return product.

    Distribution

    Worldwide, including USA, Sweden, and South Africa.

    Quantity

    640 boxes