medical Class II Updated 2019-06-26

Covidien LLC recalls SIGNIA TRI-STAPLE 2.0 BLACK 45MM EXTRA THICK RELOA, SIG45AXT

Recalled Product

SIGNIA TRI-STAPLE 2.0 BLACK 45MM EXTRA THICK RELOA, SIG45AXT

Hazard / Issue

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.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: N6E0176UX N6E0278UX N6E0584UX N6E0587UX N6E0589UX N6E0590UX N6E0975UX N6F0141UX N6F0142UX N6F0143UX N6F0144UX N6F0340UX N6F0341UX N6F0342UX N6F0343UX N6F0436UX N6G0033UX N6G0034UX N6G0035UX N6G0036UX N6G0037UX N6G0038UX N6G0125UX N6G0744UX N6H0757UX N6J0436UX N6K0010UX N6K0372UX N6K0415UX N6K0990UX N6K0991UX N6K1110UX N7C0111X N7C0381X N7C0499X N7C0611X N7D0303X
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