FDA-Device2021-01-06Class II
Covidien TA Auto Suture Vascular Loading Unit with DST Series Technology 30 mm- V3. Intended for abdominal, gynecological, pediatric and thoracic surgical procedures for resection or transection of tissue. Item Number: TA30V3L
Covidien Llc
Hazard
May contain a damaged internal component which could impede staple deployment and result in incomplete staple formation and a non-functional staple line preventing adequate hemostasis, or leading to anastomotic leak, pneumothorax, tissue damage or other delayed secondary complications including infection, peritonitis, and sepsis
Sold states
Nationwide Foreign: Canada, Albania Armenia Australia Austria Belarus Belgium Bosnia And Herzegovina Cyprus Czech Republic Egypt Estonia France Germany Greece Hungary Iceland Israel Italy Japan Jordan Korea Kuwait Latvia Libyan Arab Jamahiriya Lithuania Malaysia Martinique Morocco Myanmar, Netherlands Norway Pakistan Poland Russian Federation Serbia Singapore Slovakia Spain Sweden Switzerland Taiwan Turkey United Arab Emirates United Kingdom Viet Nam
Affected count
5316 units US; 1209 units OUS
Manufactured in
15 Hampshire St, N/A, Mansfield, MA, United States
Products
Covidien TA Auto Suture Vascular Loading Unit with DST Series Technology 30 mm- V3. Intended for abdominal, gynecological, pediatric and thoracic surgical procedures for resection or transection of tissue. Item Number: TA30V3L
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0748-2021Don't want to check this manually?
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