Reported Mar 15, 2023 · Ongoing
Tri-Staple 2.0 Black Intelligent Reload, Product Number SIG60AXT
Covidien, LP
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Covidien, LP · 60 Middletown Ave · North Haven, CT · 06473-3908
Is this the product you have?
Tri-Staple 2.0 Black Intelligent ReloadProduct Number SIG60AXT
- Lot codes and dates
- UDI-DI (GTIN)20884521543598
- Lots
N2D0002YN2D0004YN2D0195Y
- Amount recalled
- 264 US; 5056 OUS
Where it was sold
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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