Covidien Auto Suture Blunt Tip Trocar recalled for seal disengagement
Covidien is recalling approximately 11,796 Auto Suture Blunt Tip Trocar units due to potential seal disengagement when mesh products are used incorrectly with the device. The issue could occur during 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: FDA Class II recall of a surgical device with potential for malfunction during use. Meets the rubric criterion of 'risk-of-harm product where injury has not yet been reported,' scoring High (3).
Plain-English summary
Covidien, LP is recalling approximately 11,796 units of the Auto Suture Blunt Tip Trocar (Product Number OMS-T10BTSNL) distributed worldwide.
The recall addresses a potential for trocar seal disengagement when mesh products are used incorrectly with the device. This malfunction could occur during surgical procedures.
Healthcare facilities and surgical centers that have received these devices should identify affected lot numbers and discontinue use pending replacement or further instructions from Covidien. The UDI (Unique Device Identifier) is 10884521539648. Affected lot serial numbers include P0M1930, P1C1684, P1C1685, P1D1418, P1F1548, P1F1549, P1J0729, P1J1343, P1K0356, P1M0969, P2A0779, P2B0758, P2D0021, P2D0022, P2D0023, P2F0324, P2H0410, P2H0411, P2J0053, P2J0456, P2L0093, P2M0416, P2M0417, P3C0354, and P3E0462.
The recalled product
- Product
- Covidien Auto Suture" Blunt Tip Trocar, Product Number OMS-T10BTSNL
- Manufacturer
- Covidien, LP
- Affected units
- 11,796
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-T10BTSNL
- UDI/DI: 10884521539648
- Lot Serial Number: P0M1930
- P1C1684
- P1C1685
- P1D1418
- P1F1548
- P1F1549
- P1J0729
- P1J1343
- P1K0356
- P1M0969
- P2A0779
- P2B0758
- P2D0021
- P2D0022
- P2D0023
- P2F0324
- P2H0410
- P2H0411
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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