BEUDAMED
    FDA Recall Open, Classified

    Cope Mandril Wire Guide (Nitinol), Nitinol Guidewire; Reference Part Number/GPN: PMG-18SP-60-COPE-NT-ST G09395 PMG-18SP-100-COPE-NT G08687 PMG-18SP-60-COPE-NT G08427

    Recall: Z-1829-2022 · Initiated August 16, 2022

    Recall

    Recall Number
    Z-1829-2022
    Event Number
    90793
    Firm
    Cook Incorporated
    FEI Number
    1820334
    Product Code
    DQX
    Status
    Open, Classified
    Root Cause
    Under Investigation by firm
    Initiated
    August 16, 2022
    Posted
    September 28, 2022
    Address
    750 N Daniels Way, Bloomington, IN, 47404-9120

    Description

    Cope Mandril Wire Guide (Nitinol), Nitinol Guidewire; Reference Part Number/GPN: PMG-18SP-60-COPE-NT-ST G09395 PMG-18SP-100-COPE-NT G08687 PMG-18SP-60-COPE-NT G08427

    Reason

    Cook Medical identified that devices from the affected device lots may have a complete breach of the chevron seal of the packaging. Therefore, the sterility of affected devices may be compromised.

    Action

    On August 16, 2022, Cook Medical notified affected customers of the recall. Customers were instructed to immediately cease all further distribution and use of the affected products. Affected product should be quarantined and returned to Cook Medical to receive product credit. If you have any questions or concerns, please contact Cook Medical Customer Relations at 800.457.4500 or 812.339.2235

    Distribution

    Domestic distribution nationwide. Foreign distribution worldwide.

    Quantity

    1,501 US; 380 OUS