FDA-Device2020-02-26Class II
Covidien Endo GIA Ultra Universal Stapler 12 mm-intended for resection, transection in general surgery Item Code: EGIAUSTND
COVIDIEN LLC
Hazard
Potential for the sterile barrier to be compromised. Products with a compromised sterile barrier may result in a potentially increased risk for infection
Sold states
US Nationwide, Israel, and Japan
Affected count
2,180 units
Manufactured in
15 Hampshire St, Mansfield, MA, United States
Products
Covidien Endo GIA Ultra Universal Stapler 12 mm-intended for resection, transection in general surgery Item Code: EGIAUSTND
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1264-2020Don't want to check this manually?
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