BEUDAMED
    FDA Recall Terminated

    Acusnare Polypectomy (Duck Bill Shaped) Snare Used with an electrosurgical unit for endoscopic polypectomy.

    Recall: Z-1132-2019 · Initiated January 4, 2019

    Recall

    Recall Number
    Z-1132-2019
    Event Number
    81956
    Firm
    Wilson-Cook Medical Inc.
    FEI Number
    1037905
    Product Code
    KNS
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    January 4, 2019
    Terminated
    July 21, 2020
    Address
    4900 Bethania Station Rd, Winston Salem, NC, 27105-1203

    Description

    Acusnare Polypectomy (Duck Bill Shaped) Snare Used with an electrosurgical unit for endoscopic polypectomy.

    Reason

    Complaints of the snare loop not completely retracting and/or misshaping of the snare loop.

    Action

    The firm, Cook Medical, sent an"URGENT: MEDICAL DEVICE RECALL" letter to its customers. The letter described the product, problem and actions to be taken. The customer were instructed to do the following: 1. Review the labels of impacted product shipped to your account and quarantine any affected product that remains unused. If you are a distributor and the products have been distributed, contact your customer(s) and direct them to quarantine any affected product. 2. Immediately collect and return all unused affected products at one time to Cook Medical as soon as possible. Affected product should be returned to: Cook Medical Attn: Return Goods Department 053-R 400 Daniels Way Bloomington, IN 47404 3. Complete the attached Recall Return Response form and send to Cook Medical. This form may be sent via fax using the fax number: 812-339-7316 or scanned and emailed to [email protected]. Account credit will be issued to your facility upon receipt of this form with the completed information. Should you have any questions, please contact the Customer Relations Department at Cook Medical for more information. Please use [email protected], or call us toll free 1-800-457-4500, press 4, then enter extension 15-2146. Monday through Friday, 8:00AM to 4:30PM, Eastern Time.

    Distribution

    Worldwide Distribution: US (nationwide) in the states of: AL, AR, CA, CO, CT, FL, GA, HI, IA, ID, IL, IN, KS, LA, MA, MD, ME, MI, MN, MO, MS, NC, NJ, NM, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, VT, WA, WI, and WY; and countries of: ARGENTINA, BRAZIL, CANADA, MEXICO, NETHERLANDS ANTILLES, AUSTRIA, BELARUS, BELGIUM, FINLAND, FRANCE, GERMANY, ITALY, NETHERLANDS, POLAND, PORTUGAL, RUSSIAN FEDERATION, SLOVAKIA, SLOVENIA, SPAIN, SWEDEN, SWITZERLAND, UNITED ARAB EMIRATES, UNITED KINGDOM, AUSTRALIA, CHINA, INDIA, NEW ZEALAND, TAIWAN, REPUBLIC OF CHINA and THAILAND.

    Quantity

    34,456 units