Z-0748-2021 Class II
Recall Details
- Product Type
- Devices
- Report Date
- January 6, 2021
- Initiation Date
- November 23, 2020
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 5316 units US; 1209 units OUS
Product Description
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
Reason for Recall
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
Distribution Pattern
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
Code Information
Lot Numbers: P0B1335MY, P0D0170MY, P0D1445M, 0F0377MY, P0B1336MY,P0D1444MY, P0E1211MY, P0F0606MY. UDI: 10884521043152, 20884521043159