BEUDAMED
    FDA Recall Terminated

    C1140 Flexible Endoscope Processing Container and Tray assembly.

    Recall: Z-0830-03 · Initiated April 23, 2003

    Recall

    Recall Number
    Z-0830-03
    Event Number
    26151
    Firm
    Steris Corp
    FEI Number
    1527821
    Product Code
    MLR
    Status
    Terminated
    Root Cause
    Other
    Initiated
    April 23, 2003
    Posted
    May 15, 2003
    Terminated
    February 5, 2004
    Address
    5960 Heisley Rd, Mentor, OH, 44060

    Description

    C1140 Flexible Endoscope Processing Container and Tray assembly.

    Reason

    The container flow port is inverted, which restricts the flow of sterilant to the endoscope and affects the sterilization process.

    Action

    The firm notified their customers by telephone and letter on 4/23/2003.

    Distribution

    The product was shipped to end-users located nationwide and worldwide.

    Quantity

    354 units