Wilson-Cook Medical Inc.: Instinct Plus Endoscopic Clipping Device REF: G58010 Rx Only, Sterile EO
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The text below is copied from the official FDA (device) record. If anything differs, the official notice is correct.
- Company / brand
- Wilson-Cook Medical Inc.
- Product
- Instinct Plus Endoscopic Clipping Device REF: G58010 Rx Only, Sterile EO
- Reason / hazard
- Due to increased in complaints their is the potential for endoscopic clipping device to malfunction.
- Classification
- Class II
- Status
- Ongoing
- Distribution / sold at
- Worldwide - US Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, GU, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY and the countries of Argentina, AUSTRALIA, AUSTRIA, BAHRAIN, BELGIUM, Brunei, Darussalam, Brazil, Canada, CANARY ISLANDS, Chile, China, Colombia, Costa Rica, CROATIA, CYPRUS, CZECH REPUBLIC, DENMARK, Egypt, FINLAND, FRANCE, GERMANY, GREECE, Guatemala, Hong Kong, HUNGARY, Indonesia, India, IRELAND, ISRAEL, ITALIA, KUWAIT, LEBANON, LUXEMBOURG, MALTA, MAYOTTE, Mexico, Macao, MOROCCO, Malaysia, NEDERLAND, NORWAY, New Zealand, OMAN, PAKISTAN, Peru, POLAND, PORTUGAL, QATAR, REUNION, ROMANIA, SAUDI ARABIA, SLOVENIA, El Salvador, SOUTH AFRICA, SPAIN, SWEDEN, SWITZERLAND, Thailand, TURKEY, Taiwan, United Arab Emirates, United Kingdom.
- Recall initiated
- 2026-03-03
- Code info
- All Lots manufactured between 9/2/2023-04/20/2025 ; UDI: (01)10827002580104
- Product quantity
- 713,702 units
- Voluntary mandated
- Voluntary: Firm initiated
- City
- Winston Salem
- State
- NC
- Country
- United States
- Event id
- 98488
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