FDA-Device2019-06-26Class II
EGIA45 CT AR MD THK REL, EGIA45CTAMT
Covidien LLC
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.
Sold states
Nationwide domestic distribution, worldwide foreign distribution.
Affected count
3,113,280
Manufactured in
60 Middletown Ave, N/A, North Haven, CT, United States
Products
EGIA45 CT AR MD THK REL, EGIA45CTAMT
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1831-2019Don't want to check this manually?
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