BEUDAMED
    FDA Recall Terminated

    Given Imaging Limited, PillCam Express Delivery Device, For use with PillCam SB, endoscopic imaging device. Part numbers FGS-0367 (3-Pak) or FGS-0366 (1-Pak).

    Recall: Z-1748-2011 · Initiated March 8, 2011

    Recall

    Recall Number
    Z-1748-2011
    Event Number
    58137
    Firm
    Given Imaging Ltd.
    FEI Number
    3003141635
    Product Code
    NEZ
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    March 8, 2011
    Posted
    March 23, 2011
    Terminated
    December 2, 2011
    Address
    5555 Oakbrook Pkwy, Norcross, GA, 30093-6254

    Description

    Given Imaging Limited, PillCam Express Delivery Device, For use with PillCam SB, endoscopic imaging device. Part numbers FGS-0367 (3-Pak) or FGS-0366 (1-Pak).

    Reason

    The capsule holder can break away from the catheter during endoscopic procedures, necessitating retrieval.

    Action

    Given Imaging, Inc. consignees were notified via FedEx letter on/about 03/08/2011. They instructed to return all affected product. A Customer Response form with return instructions was included to be completed and returned to Given Imaging.

    Distribution

    U.S. Nationwide, Canada, Germany Israel and Australia.

    Quantity

    389