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Terminated

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

FDA Recall Z-1132-2019 · Posted None

Recall StatusTerminated
Product CodeKNS
Date Initiated2019-01-04
Date Terminated2020-07-21
Product Quantity34,456 units

Reason for Recall

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

Firm 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.

Root Cause

Nonconforming Material/Component

Distribution Pattern

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.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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