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Covidien LLC recalls SIGNIA TRI-STAPLE 2.0 BLACK 60MM EXTRA THICK RELOA, SIG60AXT
Recalled June 26, 2019 · FDA recall Z-1834-2019 · Covidien
Hazard
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. · FDA Class II
Units
3,113,280
Sold at
Nationwide domestic distribution, worldwide foreign distribution.
Description
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.
Product
SIGNIA TRI-STAPLE 2.0 BLACK 60MM EXTRA THICK RELOA, SIG60AXT
Manufacturer(s)
Covidien LLC
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →