Reported Jun 26, 2019 · Ongoing
SIGNIA TRI-STAPLE 2.0 BLACK 45MM EXTRA THICK RELOA, SIG45AXT
Covidien LLC
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 LLC · 60 Middletown Ave · North Haven, CT · 06473-3908
Is this the product you have?
- SIGNIA TRI-STAPLE 2.0 BLACK 45MM EXTRA THICK RELOA, SIG45AXT
- Lot codes and dates
N6E0176UXN6E0278UXN6E0584UXN6E0587UXN6E0589UXN6E0590UXN6E0975UXN6F0141UXN6F0142UXN6F0143UXN6F0144UXN6F0340UXN6F0341UXN6F0342UXN6F0343UXN6F0436UXN6G0033UXN6G0034UXN6G0035UXN6G0036UXN6G0037UXN6G0038UXN6G0125UXN6G0744UXN6H0757UXN6J0436UXN6K0010UXN6K0372UXN6K0415UXN6K0990UXN6K0991UXN6K1110UXN7C0111XN7C0381XN7C0499XN7C0611XN7D0303X
- Amount recalled
- 3,113,280
This recall covers 12 products
The agency filed one notice per product. You are reading one of them; the other 11 are below.
Where it was sold
- Nationwide
Why it was recalled
The device may be missing one of two pin components that maintain alignment of the device jaws, resulting in incomplete staple formation which may lead to bleeding, anastomotic leak, peritonitis, or pneumothorax which can result in the potential for infection and/or sepsis.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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