FDA-Device2024-04-10Class II
Covidien Auto Suture" Blunt Tip Trocar, Product Number OMS-T10BTNL
Covidien, LP
Hazard
The potential for trocar seal disengagement when using mesh products incorrectly with the device.
Sold states
Worldwide distribution - US Nationwide and the countries of Albania, Algeria, Aruba, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Canary Islands, Colombia, Croatia, Czech Republic, Denmark, Estonia, Finland, France, French Guiana, French Polynesia, Germany, Gibraltar, Greece, Guadeloupe, Hong Kong, Hungary, Ireland, Israel, Italy, Japan, Jordan, Kenya, Korea, Republic Of, Luxembourg, Macao, Malaysia, Malta, Martinique, Mayotte, Mexico, Netherlands, New Caledonia, New Zealand, Nigeria, Northern Ireland, Norway, Oman, Poland, Portugal, Puerto Rico, Reunion, Romania, Russian Federation, Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Trinidad And Tobago, Turkey, United Arab Emirates, United Kingdom, United States, Uzbekistan, Viet Nam, Virgin Islands, U.S.;
Affected count
315,716 units
Manufactured in
60 Middletown Ave, North Haven, CT, United States
Products
Covidien Auto Suture" Blunt Tip Trocar, Product Number OMS-T10BTNL
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1466-2024Don't want to check this manually?
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