Covidien Auto Suture Trocar Recall: Potential Seal Disengagement With Incorrect Mesh Use
Covidien is recalling 93,673 Auto Suture Blunt Tip Trocars due to potential seal disengagement when mesh products are used incorrectly. Improper use could compromise device integrity during laparoscopic procedures.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II recall of a surgical device with potential for seal disengagement. The source text does not report any illnesses, injuries, or adverse events; the hazard depends on improper use of mesh products. Classified as Score 3 (High) under the rubric criterion: 'risk-of-harm products where injury has not yet been reported.'
Plain-English summary
Covidien, LP is recalling the Auto Suture® Blunt Tip Trocar (Product Number OMS-T12BT) due to the potential for seal disengagement when mesh products are used incorrectly with the device. A total of 93,673 units have been distributed worldwide, including throughout the United States and 44 additional countries.
A trocar is a surgical instrument used in minimally invasive laparoscopic procedures. The trocar's seal is critical to maintaining the surgical environment. If the seal disengages during a procedure, it could compromise the device's performance and effectiveness.
This recall affects healthcare facilities and surgical centers that have stocked or used the affected lot numbers. The risk occurs specifically when mesh products are used with the device in ways that do not follow proper protocols. Users should verify whether they have affected units by checking the UDI and lot numbers provided in the recall notice.
Affected facilities should cease using recalled units immediately and contact Covidien, LP for instructions on product replacement or return.
The recalled product
- Product
- Covidien Auto Suture" Blunt Tip Trocar, Product Number OMS-T12BT
- Manufacturer
- Covidien, LP
- Hazard
- seal-disengagement
- equipment-failure
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 (20)
- Product Number/CFN: OMS-T12BT
- UDI/DI: 20884521081090
- 10884521081093
- Lot Serial Number: P1C1924
- P1D0400
- P1D1411
- P1D1412
- P1D1508
- P1F1483
- P1F1484
- P1F1485
- P1F1591
- P1G0141
- P1G1118
- P1G1120
- P1H0046
- P1H0047
- P1H0048
- P1H0861
- P1H0862
Distribution
Distributed nationwide across the United States.
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