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
Check against the official notice below — it lists the full affected range.
Covidien is recalling certain TA Auto Suture Vascular Loading Units with DST Series Technology (30 mm) used in abdominal, gynecological, pediatric, and thoracic surgical procedures. The devices may contain a damaged internal component that could prevent proper staple deployment, resulting in incomplete or non-functional staple formation. This defect could fail to provide adequate hemostasis (bleeding control) or lead to serious complications including anastomotic leak, pneumothorax, tissue damage, infection, peritonitis, and sepsis.
The recall affects 5,316 units in the United States and 1,209 units internationally across numerous countries including Canada, Australia, France, Germany, Japan, and others. The affected devices are identified by specific lot numbers (P0B1335MY, P0D0170MY, P0D1445M, 0F0377MY, P0B1336MY, P0D1444MY, P0E1211MY, P0F0606MY) and UDI codes. The source document does not specify a remedy or instructions for affected consumers.
Written by software from the official notice below. Not reviewed by a lawyer.
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
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: 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 Taiw Quantity: 5316 units US; 1209 units OUS Lot/code info: Lot Numbers: P0B1335MY, P0D0170MY, P0D1445M, 0F0377MY, P0B1336MY,P0D1444MY, P0E1211MY, P0F0606MY. UDI: 10884521043152, 20884521043159
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.