BEUDAMED
    FDA Recall Terminated

    Cook Harrison fetal bladder stent set, sterile; REF J-HFBS-503540.

    Recall: Z-0674-06 · Initiated March 1, 2006

    Recall

    Recall Number
    Z-0674-06
    Event Number
    34671
    Firm
    Cook Urological, Inc.
    FEI Number
    1825146
    Product Code
    FAD
    Status
    Terminated
    Root Cause
    Other
    Initiated
    March 1, 2006
    Posted
    March 23, 2006
    Terminated
    July 1, 2008
    Address
    1100 W Morgan St, Spencer, IN, 47460-9426

    Description

    Cook Harrison fetal bladder stent set, sterile; REF J-HFBS-503540.

    Reason

    Instructions for Use (IFU) booklet missing pages 5-12. Pages 5-8 in English; 9-12 in Danish, describe stent duration, patient preparation, assembly, implanting, follow-up and removal instructions. IFU, device description, indications, contraindications, warnings, precautions, patient counseling, clinical usage, clinical study data, adverse events. One patient booklet lacked pages 3-6, & 55-58.

    Action

    Consignees were notified via letter dated 3/1/06 that included one copy of the instructions. Consignees were asked to inform the firm of how many additional copies were needed for stocks on hand and instructed to make copies as needed until additional supplies are received.

    Distribution

    Nationwide, Australia, Canada, Caracas, Chile, Colombia, Hong Kong, India, Ireland, Israel, Malaysia, Mexico, New Zealand, Paraguay, Taiwan and Venezuela.

    Quantity

    1300