FDA-Device2024-06-05Class II
Tri-Staple 2.0 Black Reinforced Intelligent Reload- Applications in abdominal, gynecologic, pediatric and thoracic surgery for resection, transection of tissue and creation of anastomosis Model: SIGTRSB60AXT
Covidien, LP
Hazard
Potential damage to the cartridge can result in poor staple formation and/or incomplete staple line, may cause a delay in surgery
Sold states
Worldwide - US Nationwide distribution in the state of NJ and the countries of Australia, Japan, New Zealand, Saudi Arabia, Singapore, South Africa, Taiwan, Thailand.
Affected count
1681 units
Manufactured in
60 Middletown Ave, North Haven, CT, United States
Products
Tri-Staple 2.0 Black Reinforced Intelligent Reload- Applications in abdominal, gynecologic, pediatric and thoracic surgery for resection, transection of tissue and creation of anastomosis Model: SIGTRSB60AXT
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1891-2024Don't want to check this manually?
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