BEUDAMED
    FDA Recall Terminated

    Boston Scientific 1.0mm x 570 mm rigid pneumatic probe for use only with Swiss LithoClast Select System model no. 840-300K, Swiss LithoClast Ultra System model nol 840-700K, or Swiss LithoClast Ultra Upgraded System model no. 840-701U, compatible with 330mm Ultrasound Probes (REF 840-714 and 840-715), Rx, sterile, no detectable latex, Packaged and Distributed by Boston Scientific Corporation, Natick, MA; REF/catalog no 840-733.

    Recall: Z-0175-2010 · Initiated September 17, 2009

    Recall

    Recall Number
    Z-0175-2010
    Event Number
    53582
    Firm
    Boston Scientific Corp
    FEI Number
    1828132
    Product Code
    FFK
    Status
    Terminated
    Root Cause
    Other
    Initiated
    September 17, 2009
    Posted
    November 11, 2009
    Terminated
    October 8, 2010
    Address
    780 Brookside Dr, Spencer, IN, 47460-1080

    Description

    Boston Scientific 1.0mm x 570 mm rigid pneumatic probe for use only with Swiss LithoClast Select System model no. 840-300K, Swiss LithoClast Ultra System model nol 840-700K, or Swiss LithoClast Ultra Upgraded System model no. 840-701U, compatible with 330mm Ultrasound Probes (REF 840-714 and 840-715), Rx, sterile, no detectable latex, Packaged and Distributed by Boston Scientific Corporation, Natick, MA; REF/catalog no 840-733.

    Reason

    The label incorrectly reads "compatible with 330mm ultrasound probes (Ref 840-714 and 840-715)" instead of bearing the correct statement "compatible with 403mm ultrasound probes (Ref 840-716 and 840-7170."

    Action

    Consignees were notified by letter titled "Urgent Medical Device Recall-Immediate Action Required" dated 9/17/09 and instructed to cease using the product and to call the firm's customer service for return authorization. For additional information, call the firm at 866-868-4004.

    Distribution

    Nationwide.

    Quantity

    173