Covidien Auto Suture Trocar Recalled for Potential Seal Disengagement
Covidien is recalling approximately 124,863 Auto Suture Structural Balloon Trocars worldwide due to potential seal disengagement when used incorrectly with mesh products.
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 a Class II medical device recall for surgical trocars with potential for seal disengagement that could compromise surgical procedures. No injuries or deaths have been reported. Per the rubric, risk-of-harm products without reported injury are classified as High (3).
Plain-English summary
Covidien, LP is recalling the Auto Suture Structural Balloon Trocar (Product Number OMS-T10SB). Approximately 124,863 units are affected by this Class II recall, with specific lot serial numbers ranging from P0B1097Y through P3L0821.
The recall addresses a potential for trocar seal disengagement when mesh products are used incorrectly with the device. This issue may occur during surgical procedures.
The affected trocars have been distributed worldwide, including throughout the United States and to more than 50 countries including Canada, United Kingdom, Australia, Japan, and Germany. Healthcare facilities using these devices should identify affected units by product number and lot serial numbers.
Patients and healthcare providers should contact Covidien, LP if they have questions about these devices or have experienced issues with seal disengagement.
The recalled product
- Product
- Covidien Auto Suture" Structural Balloon Trocar, Product Number OMS-T10SB
- Manufacturer
- Covidien, LP
- Hazard
- Affected units
- 124,863
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-T10SB
- UDI/DI: 20884521081083 and 10884521081086
- Lot Serial Number: P0B1097Y
- P0L1408
- P0L1442
- P0M1720
- P0M1721
- P0M1931
- P1A1469
- P1A1470
- P1A1485
- P1A1486
- P1B1294
- P1B1449
- P1C0441
- P1C1565
- P1C1566
- P1C1568
- P1C1674
- P1C1675
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 7 recalled by Covidien, LP 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.
See all 7 products in this recall →Related recalls
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Same hazard · seal disengagement
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