FDA-Device2019-04-24Class II
Acusnare Polypectomy (Duck Bill Shaped) Snare Used with an electrosurgical unit for endoscopic polypectomy.
Wilson-Cook Medical Inc.
Hazard
Complaints of the snare loop not completely retracting and/or misshaping of the snare loop.
Sold states
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.
Affected count
34,456 units
Manufactured in
4900 Bethania Station Rd, N/A, Winston Salem, NC, United States
Products
Acusnare Polypectomy (Duck Bill Shaped) Snare Used with an electrosurgical unit for endoscopic polypectomy.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1132-2019Don't want to check this manually?
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