BEUDAMED
    FDA Recall Terminated

    Adapter for ACMI Hysteroscope Catalog Number: 55035

    Recall: Z-1020-05 · Initiated July 28, 2005

    Recall

    Recall Number
    Z-1020-05
    Event Number
    32601
    Firm
    Boston Scientific Marlbourgh
    FEI Number
    3005099803
    Product Code
    MNB
    Status
    Terminated
    Root Cause
    Other
    Initiated
    July 28, 2005
    Posted
    July 19, 2005
    Terminated
    June 14, 2006
    Address
    100 Fairbanks Blvd, Marlborough, MA, 01752-1234

    Description

    Adapter for ACMI Hysteroscope Catalog Number: 55035

    Reason

    The Hysteroscope Adapter used with the HTA System may disassemble and result in a fluid leak.

    Action

    Boston Scientifc notified accounts by letter dated June 28, 2005 via Federal Express. Accounts are requested to check invnetory and return. Any adapters out of box have no lot identification and can be tested per instructions

    Distribution

    CA, DE, FL, MA, MO, MS, OH, NE, NY, PA, UT, WI