Recall record at a glance
| Official record | Z-1132-2019 |
|---|---|
| Category | Medical Device Recalls |
| Classification | Class II |
| FDA record status | Terminated |
| Recalling firm | Wilson-Cook Medical Inc. |
| Report date | Apr 24, 2019 |
| Recall initiation date | Jan 4, 2019 |
| Quantity | 34,456 units |
| Location | Winston Salem, NC, United States |
Official product description
Acusnare Polypectomy (Duck Bill Shaped) Snare Used with an electrosurgical unit for endoscopic polypectomy.
Why the product was recalled
Complaints of the snare loop not completely retracting and/or misshaping of the snare loop.
Distribution information
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.
How to read the classification
FDA Class II indicates a situation in which use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or where the probability of serious consequences is remote. The classification shown here comes from the FDA record.
Additional record details
Recall type: Voluntary: Firm initiated. Initial notification: Letter.
What to do next
If you believe you have the recalled product, use the recall number and firm information above to confirm the official notice and follow the instructions issued by the FDA, recalling firm, retailer or product manufacturer. For drugs and medical devices, decisions about treatment or medical care should be discussed with a qualified health professional.
About this record
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