BEUDAMED
    FDA Recall Terminated

    C1406, QLC1406, C1473, and QLC1473 Quick Connect for Olympus 30/40/160/200/240 Series Bronchoscopes in the C1140 Universal Processing Trays. Catalog numbers: C11473 and QLC1473.

    Recall: Z-0547-03 · Initiated March 7, 2003

    Recall

    Recall Number
    Z-0547-03
    Event Number
    25374
    Firm
    Steris Corp
    FEI Number
    1527821
    Product Code
    MLR
    Status
    Terminated
    Root Cause
    Other
    Initiated
    March 7, 2003
    Posted
    February 6, 2003
    Terminated
    February 5, 2004
    Address
    5960 Heisley Rd, Mentor, OH, 44060

    Description

    C1406, QLC1406, C1473, and QLC1473 Quick Connect for Olympus 30/40/160/200/240 Series Bronchoscopes in the C1140 Universal Processing Trays. Catalog numbers: C11473 and QLC1473.

    Reason

    The Steris device may not attach properly to retrofitted Olympus bronchoscopes, and become loose during the sterile processing cycle.

    Action

    On 3/14/2002 by mail and 2/21/2003 by fax. The units will be replaced.

    Distribution

    Nationwide. Some foreign distribution into Canada, Italy, Greece, Australia, New Zealand, UK, Brussels, Norway, Zaire, Spain, Behrain, Israel.

    Quantity

    1,140 units