FDA recall Z-1132-2019

Product

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

Reason for recall

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

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.

Key facts

Status

Terminated

Initiation date

2019-01-04

Report date

2019-04-24

Termination date

2020-07-21

Voluntary/Mandated

Voluntary: Firm initiated

Location

Winston Salem, NC, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1132-2019