BEUDAMED
    FDA Recall Terminated

    Pump Tube, REF 8170,121; Suction Pump Drain Tube; An accessory to the suction pump designed for use with the Richard Wolf Ultrasound Lithotriptor used to disintegrate kidney stones, urinary bladder stones and ureter stones; Richard Wolf GmbH, D-75438 Knittlingen Germany

    Recall: Z-0537-04 · Initiated February 2, 2004

    Recall

    Recall Number
    Z-0537-04
    Event Number
    28227
    Firm
    Richard Wolf Medical Instruments Corp.
    FEI Number
    1418479
    Product Code
    JOL
    Status
    Terminated
    Root Cause
    Other
    Initiated
    February 2, 2004
    Posted
    February 11, 2004
    Terminated
    March 24, 2004
    Address
    353 Corporate Woods Pkwy, Vernon Hills, IL, 60061-3110

    Description

    Pump Tube, REF 8170,121; Suction Pump Drain Tube; An accessory to the suction pump designed for use with the Richard Wolf Ultrasound Lithotriptor used to disintegrate kidney stones, urinary bladder stones and ureter stones; Richard Wolf GmbH, D-75438 Knittlingen Germany

    Reason

    If the drain tube is assembled incorrectly, the suction pump will not operate as intended.

    Action

    The accounts were telephoned on 2/2/04 and informed of the potential to re-assemble the suction pump drain tubing incorrectly after sterilization. The accounts were sent re-designed replacement tubing sets and were requested to return the old tubing sets to Richard Wolf.

    Distribution

    Texas and Nebraska

    Quantity

    2 tube sets