FDA-Device2018-02-28Class II
Endo GIA Auto Suture Universal Articulating Loading Unit for use in abdominal, gynecologic, pediatric and thoracic surgery for resection, transection and creation of anastomosis.
Covidien LLC
Hazard
Potential for failure of the device safety interlock. The safety interlock prevents an empty single-use loading unit from being fired a second time.
Sold states
Nationally
Affected count
3,816
Manufactured in
60 Middletown Ave, N/A, North Haven, CT, United States
Products
Endo GIA Auto Suture Universal Articulating Loading Unit for use in abdominal, gynecologic, pediatric and thoracic surgery for resection, transection and creation of anastomosis.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0636-2018Don't want to check this manually?
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