BEUDAMED
    FDA Recall Terminated

    Endoscopic Curved Needle, Surgical Needle Guide, Supplied sterilized by ethylene oxide gas in peel-open packages. Used for internal suturing under direct vision during intraabdominal endoscopic procedures. The needle driver design affords precise placement and control of standard curved suture needles, similar to open abdominal suturing.

    Recall: Z-2313-2017 · Initiated May 1, 2017

    Recall

    Recall Number
    Z-2313-2017
    Event Number
    77167
    Firm
    Cook Inc.
    FEI Number
    1820334
    Product Code
    FHQ
    Status
    Terminated
    Root Cause
    Under Investigation by firm
    Initiated
    May 1, 2017
    Terminated
    March 26, 2019
    Address
    750 N Daniels Way, Bloomington, IN, 47404-9120

    Description

    Endoscopic Curved Needle, Surgical Needle Guide, Supplied sterilized by ethylene oxide gas in peel-open packages. Used for internal suturing under direct vision during intraabdominal endoscopic procedures. The needle driver design affords precise placement and control of standard curved suture needles, similar to open abdominal suturing.

    Reason

    COOK Medical is initiating a voluntary recall of multiple products because the reprocessing instructions do not provide sufficient detailed information for the cleaning, disinfection, and sterilization of these products.

    Action

    The firm, Cook Medical, sent an "URGENT: MEDICAL DEVICE RECALL" letter dated April 26, 2017 to its customers. Letters were mailed to customers via courier on April 28, 2017. The letter described the product, problem, and actions to be taken. The customers were instructed to: examine your inventory immediately to identify and quarantine affected products; complete and return the required Acknowledgment and Receipt form (even if you do not have affected product) via fax (812.339.7316) or email ([email protected]); return and discard any affected products, and Immediately report any adverse events to Cook Medical Customer Relations at 800.457.4500 or 812.339.2235, Monday through Friday between 7:30 am and 5:00 pm (Eastern Time), or by email at [email protected]. Should you have any medical questions or concerns, please contact Cook Medical Customer Relations at 800.457.4500 or 812.339.2235.

    Distribution

    Worldwide Distribution - US (nationwide) and countries of: Australia, Austria, Belgium, Bahrain, Canada, China, Costa Rica, Finland, France, Germany, Hong Kong, India, Ireland, Italy, Lithuania, Latvia, Malaysia, Netherlands, Romania, Russia, Saudi Arabia, Singapore, Spain, Switzerland, United Arab Emirates, and United Kingdom.

    Quantity

    327 Lots, 725 units