Tri-Staple 2.0 Black Intelligent Reload, Product Number SIG60AXT
FDA Recall #Z-1228-2023 — Class II — January 25, 2023
Product Description
Tri-Staple 2.0 Black Intelligent Reload, Product Number SIG60AXT
Reason for Recall
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.
Recalling Firm
Covidien, LP — North Haven, CT
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
264 US; 5056 OUS
Distribution
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.
Code Information
UDI-DI (GTIN): 20884521543598 Lots: N2D0002Y, N2D0004Y, N2D0195Y
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated