FDA Recalls Covidien TA Auto Suture Vascular Loading Units
FDA is recalling specific lots of Covidien TA Auto Suture Vascular Loading Units due to a damaged internal component that may prevent adequate hemostasis.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II and involves a medical device defect that can lead to serious injuries such as sepsis, peritonitis, and pneumothorax, meeting the criteria for a Severe rating.
Plain-English summary
The U.S. Food and Drug Administration (FDA) is recalling specific lots of the Covidien TA Auto Suture Vascular Loading Unit with DST Series Technology 30 mm- V3. The affected item number is TA30V3L. This medical device is intended for abdominal, gynecological, pediatric, and thoracic surgical procedures for the resection or transection of tissue.
The recall was initiated because the device may contain a damaged internal component. This defect could impede staple deployment, resulting in incomplete staple formation and a non-functional staple line. Such a failure may prevent adequate hemostasis or lead to anastomotic leak, pneumothorax, tissue damage, or other delayed secondary complications, including infection, peritonitis, and sepsis.
A total of 5,316 units were distributed in the United States and 1,209 units were distributed outside the U.S. The affected lot numbers are P0B1335MY, P0D0170MY, P0D1445M, 0F0377MY, P0B1336MY, P0D1444MY, P0E1211MY, and P0F0606MY. The associated UDI codes are 10884521043152 and 20884521043159. Healthcare facilities and distributors should check their inventory for these specific lot numbers and stop using the affected devices.
The recalled product
- Product
- 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
- Manufacturer
- Covidien Llc
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (9)
- Lot Numbers: P0B1335MY
- P0D0170MY
- P0D1445M
- 0F0377MY
- P0B1336MY
- P0D1444MY
- P0E1211MY
- P0F0606MY. UDI: 10884521043152
- 20884521043159
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 recalled by Covidien Llc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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