FDA-Device2023-03-15Class II
Tri-Staple 2.0 Black Intelligent Reload, Product Number SIG60AXT
Covidien, LP
Hazard
Affected lots have the potential for a broken sled vane, which may cause the reload to misfire leading to non-functional staple line closure, transecting tissue without forming staples, and tissue hang-up. These conditions may be associated to a delay to treatment, unspecified infection, hemorrhage/blood loss/bleeding, failure to anastomose, peritonitis, sepsis, pneumothorax, tissue trauma, or death.
Sold states
Worldwide distribution - US Nationwide distribution in the states of Arkansas, California, Florida, Georgia, Louisiana, Massachusetts, New York, North Carolina, Ohio, Washington and the countries of Australia, Austria, Belgium, Canada, Canary Islands, Denmark, Finland, France, Germany, Ireland, Italy, Kuwait, Netherlands, New Caledonia, Norway, Poland, Portugal, Spain, Sweden, Switzerland, United Kingdom.
Affected count
264 US; 5056 OUS
Manufactured in
60 Middletown Ave, North Haven, CT, United States
Products
Tri-Staple 2.0 Black Intelligent Reload, Product Number SIG60AXT
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1228-2023Don't want to check this manually?
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