Covidien Auto Suture Blunt Tip Trocar Recalled for Seal Disengagement Risk
Covidien Auto Suture Blunt Tip Trocar devices are recalled due to potential seal disengagement when using mesh products incorrectly with the device. This malfunction risk affects surgical procedures.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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 classified as FDA Class II with a potential device malfunction (seal disengagement) that could affect surgical outcomes. No illnesses or injuries are reported in the source. The hazard is theoretical pending actual use with mesh products, placing it at the High level per the rubric for risk-of-harm devices without reported injuries.
Plain-English summary
Covidien, LP has recalled the Auto Suture Blunt Tip Trocar (Product Number OMS-T10BTNL) due to a potential for trocar seal disengagement when using mesh products incorrectly with the device. The seal disengagement could compromise device function during surgical procedures.
Approximately 315,716 units have been distributed worldwide, including throughout the United States and to over 50 countries. The recall affects specific lot numbers, which are identified in the recall documentation.
Healthcare facilities and surgical teams should check their inventories against the affected lot numbers. Proper technique when using mesh products with this trocar is critical to prevent seal disengagement. Facilities should contact Covidien directly for instructions on device return or alternatives.
The recalled product
- Product
- Covidien Auto Suture" Blunt Tip Trocar, Product Number OMS-T10BTNL
- Manufacturer
- Covidien, LP
- Affected units
- 315,716
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-T10BTNL
- UDI/DI: 20884521527383
- 10884521527386
- Lot Serial Number: P0L1440
- P0L1441
- P0M1916
- P0M1941
- P1A1541
- P1C0413
- P1C0414
- P1C0415
- P1C1569
- P1C1570
- P1C1669
- P1C1670
- P1C1671
- P1C1672
- P1C1792
- P1C1793
- P1C1921
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.
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