Covidien Auto Suture Blunt Tip Trocar Seal Disengagement Recall
Covidien Auto Suture Blunt Tip Trocar units may experience seal disengagement when mesh products are used incorrectly with the device. Healthcare facilities should discontinue use of affected units and contact Covidien for guidance.
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 medical device recall with no reported incidents or injuries mentioned in the source material. However, trocar seal disengagement during surgical use represents a risk-of-harm scenario with potential for significant patient injury, meeting the threshold for a High severity rating.
Plain-English summary
Covidien, LP is recalling 165,356 units of the Covidien Auto Suture™ Blunt Tip Trocar (Product Number OMS-T10BT) due to the potential for trocar seal disengagement when mesh products are used incorrectly with the device.
This potential disengagement creates a risk for patients and medical professionals during surgical procedures. The vulnerability may affect the proper function of the trocar during surgical use with mesh products.
The affected units were distributed worldwide, including throughout the United States and numerous international countries. Multiple lot numbers are involved in this recall. Healthcare facilities should identify and secure any affected units from their inventory.
If you have the affected Covidien Auto Suture Blunt Tip Trocar units, stop using them immediately. Contact Covidien, LP for instructions on how to return, replace, or properly dispose of the affected devices. Healthcare providers should verify their lot numbers against the recall information to identify affected inventory.
The recalled product
- Product
- Covidien Auto Suture" Blunt Tip Trocar, Product Number OMS-T10BT
- Manufacturer
- Covidien, LP
- Hazard
- seal-disengagement
- surgical-device-defect
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-T10BT
- UDI/DI: 10884521080874
- 20884521080871
- Lot Serial Number: P1D1353
- P1D1353
- P1D1355
- P1D1409
- P1D1410
- P1D1506
- P1D1507
- P1E1402
- P1E1403
- P1E1505
- P1E1506
- P1F0061
- P1F0062
- P1F0063
- P1F1018
- P1F1019
- P1F1388
Distribution
Distributed nationwide across the United States.
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