BEUDAMED
    FDA Recall Terminated

    Irrigation Aspiration System with Double Spike Tubing and 33 cm Probe, Disposable (single use only), sterile, latex free. Catalog # 55060. HYDRO-PRO brand labeled as sold by Vital Concepts, Inc., Grand Rapids, Michigan. Huntington Instruments brand labeled as Manufactured for Huntington Instruments, Ogden Utah. Quanta Technologies L.L.C. brand Manufactured for Quanta Technologies, L.L.C., Tucson, AZ. Catalogue # 55060-10 sold in Canada and labeled as Manufactured for Jac-Cell Medic, Dorval, Quebec.

    Recall: Z-0021-04 · Initiated July 11, 2003

    Recall

    Recall Number
    Z-0021-04
    Event Number
    27131
    Firm
    Vital Concepts, Inc.
    FEI Number
    1000115375
    Product Code
    GCY
    Status
    Terminated
    Root Cause
    Other
    Initiated
    July 11, 2003
    Posted
    October 15, 2003
    Terminated
    April 12, 2004
    Address
    5090 Kendrick Ct. S E, Grand Rapids, MI, 49512

    Description

    Irrigation Aspiration System with Double Spike Tubing and 33 cm Probe, Disposable (single use only), sterile, latex free. Catalog # 55060. HYDRO-PRO brand labeled as sold by Vital Concepts, Inc., Grand Rapids, Michigan. Huntington Instruments brand labeled as Manufactured for Huntington Instruments, Ogden Utah. Quanta Technologies L.L.C. brand Manufactured for Quanta Technologies, L.L.C., Tucson, AZ. Catalogue # 55060-10 sold in Canada and labeled as Manufactured for Jac-Cell Medic, Dorval, Quebec.

    Reason

    The suction valve may become stuck in the 'suction on' position under vacuum.

    Action

    A request for product return was sent to each customer beginning on July 11, 2003.

    Distribution

    Arizona, Illinois, Indiana, Michigan, Ohio, Pennsylvania, South Carolina, Texas, Utah, Washington, Canada, Israel and Japan

    Quantity

    2333