FDA Devices Moderate Class II Terminated

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

Reported: April 24, 2019 Initiated: January 4, 2019 #Z-1132-2019

Product Description

Reason for Recall

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

Details

Recalling Firm: Wilson-Cook Medical Inc.
Units Affected: 34,456 units
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.
Location: Winston Salem, NC

Frequently Asked Questions

What product was recalled? ▼

Acusnare Polypectomy (Duck Bill Shaped) Snare Used with an electrosurgical unit for endoscopic polypectomy.. Recalled by Wilson-Cook Medical Inc.. Units affected: 34,456 units.

Why was this product recalled? ▼

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

Which agency issued this recall? ▼

This recall was issued by the FDA Devices on April 24, 2019. Severity: Moderate. Recall number: Z-1132-2019.