BEUDAMED
    FDA Recall Terminated

    COOK Stiffened Micropuncture Introducer Set, 5 FR. Product Reorder Number: MPIS-501-10.0-SC-U

    Recall: Z-0434-03 · Initiated November 25, 2002

    Recall

    Recall Number
    Z-0434-03
    Event Number
    25109
    Firm
    Cook, Inc.
    FEI Number
    1820334
    Product Code
    DYB
    Status
    Terminated
    Root Cause
    Other
    Initiated
    November 25, 2002
    Posted
    February 28, 2003
    Terminated
    March 21, 2003
    Address
    750 Daniels Way P.O. Box 489, Bloomington, IN, 47402-0489

    Description

    COOK Stiffened Micropuncture Introducer Set, 5 FR. Product Reorder Number: MPIS-501-10.0-SC-U

    Reason

    The tip of the stiffened cannula might break during use and remain in the patient.

    Action

    Recall letters were sent to each customer on November 26, 2002 advising them of the recall and to return stocks on hand.

    Distribution

    United States, Brazil, Canada, Dominican Republic and Israel.

    Quantity

    393