BEUDAMED
    FDA Recall Terminated

    Boston Scientific Radial Jaw 4 Large Capacity w/Needle Biopsy Forceps Box 80, 240cm UPN/Catalog Number: M00513334

    Recall: Z-1773-2010 · Initiated May 6, 2010

    Recall

    Recall Number
    Z-1773-2010
    Event Number
    55740
    Firm
    Boston Scientific Corporation
    FEI Number
    3005099803
    Product Code
    FCL
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    May 6, 2010
    Posted
    June 4, 2010
    Terminated
    September 20, 2011
    Address
    100 Boston Scientific Way, Marlborough, MA, 01752-1234

    Description

    Boston Scientific Radial Jaw 4 Large Capacity w/Needle Biopsy Forceps Box 80, 240cm UPN/Catalog Number: M00513334

    Reason

    Clevis may detach from the coil preventing the device to open and/or close. Delays in the procedure may result.

    Action

    Boston Scientific issued Recall notification letters via Federal Express Priority mail on May 6, 2010. The notification instructs the account to check their inventory, remove any affected product from their inventory, and return it to Boston Scientific. The notification also requests the completion of a Reply Verification Tracking Form as a method of documenting the presence or absence of affected product from their inventory. In the letter, customers with questions are provided with a phone and email at the firm to contact.

    Distribution

    Nationwide; Panama.