FDA-Device2013-04-17Class II

Covidien Endo GIA AutoSuture Universal Loading Unit, 30mm-2.0mm Product Code: 030450 Applications in abdominal, gynecologic, pediatric anti thoracic surgery for resection, transection and creation of anastomosis.

Covidien LP
Hazard

Single Use Loading Unit contained two staples loaded in each cartridge pocket and may result in difficulty firing and removing the device from the application site, which may require medical intervention

Sold states
Worldwide Distribution -- USA, Asia Pacific, Canada, Europe, and Japan.
Affected count
6,751 units
Manufactured in
60 Middletown Ave, North Haven, CT, United States
Products
Covidien Endo GIA AutoSuture Universal Loading Unit, 30mm-2.0mm Product Code: 030450 Applications in abdominal, gynecologic, pediatric anti thoracic surgery for resection, transection and creation of anastomosis.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1063-2013

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