BEUDAMED
    FDA Recall Terminated

    Disposable Hemostasis Clip, DCH-7-230, Rx only, Single Use only, Cook Medical Product Usage: This device is used for endoscopic clip placement within the gastrointestinal tract for the purpose of endoscopic marking, hemostasis for mucosal sub-mucosal defects less thank 3cm in the upper GI tract, bleeding ulcers, arteries les than 2 mm, and polyps less than 1.5cm in diameter in the GI tract,. This device is not intended for the repair of GI tract luminal perforations.

    Recall: Z-2691-2011 · Initiated June 7, 2011

    Recall

    Recall Number
    Z-2691-2011
    Event Number
    59039
    Firm
    Cook Endoscopy
    FEI Number
    1037905
    Product Code
    MND
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    June 7, 2011
    Posted
    June 28, 2011
    Terminated
    May 15, 2012
    Address
    5951 Grassy Creek Blvd, Winston Salem, NC, 27105-1206

    Description

    Disposable Hemostasis Clip, DCH-7-230, Rx only, Single Use only, Cook Medical Product Usage: This device is used for endoscopic clip placement within the gastrointestinal tract for the purpose of endoscopic marking, hemostasis for mucosal sub-mucosal defects less thank 3cm in the upper GI tract, bleeding ulcers, arteries les than 2 mm, and polyps less than 1.5cm in diameter in the GI tract,. This device is not intended for the repair of GI tract luminal perforations.

    Reason

    The disposable clip may not deploy after being positioned inside the patient.

    Action

    Wilson-Cook Medical, Inc. (Cook Endoscopy) sent an "URGENT: PRODUCT RECALL" notice dated June 7, 2011 and a "PRODUCT RECALL EFFECTIVENESS SURVEY' dated June 21, 2011 to all affected consignees. The notice described the product, problem, and actions to be taken. Medical users were instructed to quarantine any affected products and return to Cook Medical. The distributors were instructed to contact their customers and coordinate the return of the affected products to Cook Medical. The recalled notice and survey should be completed and returned to Cook Medical via fax to 812-339-7316 or scanned and emailed to [email protected]. If you have any questions regarding this matter, please contact the Customer Relations Department at toll free-1-800-457-4500, press 4 then enter extension 2146 or by email at [email protected] .

    Distribution

    (USA) Nationwide Distribution including the states of: CA, HI, MA, ME, NC and NY.

    Quantity

    307 units