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

Recall date

May 17, 2019

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1833-2019

FDA classification

Class II

Brand / firm

Covidien LLC

Sold / distributed

Nationwide domestic distribution, worldwide foreign distribution.

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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