Monosof nylon sutures recalled for sterile barrier breach
Covidien is recalling Monosof nylon sutures due to sterile barrier breach in the breather pouch, which may cause infection or vision loss in ophthalmic procedures. The recall affects 54,288 units distributed nationwide and globally.
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: FDA Class II recall involving a direct contamination risk to sterile surgical products. The sterile barrier breach presents a significant potential for patient harm (infection or vision loss) in ophthalmic procedures. The source describes potential hazards rather than confirmed illnesses, fitting the rubric criterion for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Covidien, LP is recalling Monosof monofilament nylon sutures in multiple product configurations due to a sterile barrier breach of the breather pouch. The breach may allow contamination that could cause infection or vision loss when the sutures are used in ophthalmic (eye) procedures involving direct patient contact.
The recall affects 54,288 units of various Monosof suture products distributed nationwide in the United States and internationally to numerous countries. Multiple product codes and lot numbers are affected as specified in the FDA recall notice.
This is an FDA Class II medical device recall.
The recalled product
- Product
- Monosof Monofilament Nylon sutures: Product Description CN-724 MONOSOF* 1 BLK 100CM GS25 X36 CN-791 MONOSOF* 2-0 BLK 100CM GCC90X36 CN-791-12 MONOSOF* 2-0 BLK 100CM GCC90 CN-793 MONOSOF* 1 BLK 100CM GCC90 X36 CN-793-12 MONOSO
- Manufacturer
- Covidien, LP
- Hazard
- sterile-barrier-breach
- infection-risk
- vision-loss
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)
- GTIN: 20884521075105
- 20884521075235
- 10884521075238
- 20884521075143
- 10884521635395
- 20884521077857
- 20884521075372
- 20884521078090
- 20884521077994
- 20884521079073
- 10884521080348
- 20884521080345
- 20884521080321
- 10884521080324
- 10884521078758
- 20884521078755
- 20884521078182
- 20884521078045
- 20884521075129
- 10884521635371
Distribution
Distributed nationwide across the United States.
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