Surgilon Braided Nylon sutures recalled due to sterile barrier defect
Covidien is recalling Surgilon Braided Nylon sutures due to a sterile barrier breach in the breather pouch that could allow bacterial contamination, potentially causing infection or vision loss in ophthalmic procedures.
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 FDA Class II recall involves a manufacturing defect that could compromise sterile barrier integrity in surgical sutures used in vision-critical ophthalmic procedures. The source text does not report any illnesses or injuries, and the hazard is potential rather than confirmed, placing this at the risk-of-harm level with no reported injuries.
Plain-English summary
Covidien, LP is recalling multiple lot numbers of Surgilon Braided Nylon sutures, a sterile surgical suture used in medical procedures. The recall is due to a sterile barrier breach in the breather pouch that may allow microorganisms to enter the package, compromising the sterility of the sutures.
A breach in the sterile barrier can result in bacterial contamination of the sutures. When contaminated sutures are used in ophthalmic procedures (eye surgery) where there is direct patient contact, there is a potential risk of infection or vision loss.
The recalled sutures were distributed nationwide in the United States and to numerous countries worldwide. Approximately 87,708 units were distributed. Multiple product codes and lot numbers are affected, as detailed in FDA's recall notice.
Healthcare facilities and surgeons should stop using the affected sutures immediately and quarantine any remaining inventory. The sutures should not be used in patient procedures. For specific lot numbers and product codes affected, healthcare providers should consult the FDA recall notice or contact Covidien directly for full details.
The recalled product
- Product
- Surgilon Braided Nylon suture Product Description: 88861883-51 SURGILON* 2-0 BLK 75CM C16 88861915-71 SURGILON* 1 BLK 75CM GS11 88861919-31 SURGILON* 4-0 BLK 7X75CMPCT 88861919-41 SURGILON* 3-0 BLK 7X75CMPCT 88861919-51 SURGILON* 2-0 BLK 7X75CMPCT 88861919-61 SURGILON* 0 B
- Manufacturer
- Covidien, LP
- Hazard
- sterile-barrier-breach
- bacterial-contamination
- infection
- 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 (18)
- GTIN: 20884521073996
- 20884521076652
- 10884521072183
- 20884521072180
- 10884521071223
- 20884521071220
- 10884521071797
- 20884521071794
- 20884521071763
- 20884521071787
- 20884521071749
- 10884521073838
- 20884521073835
- 20884521076669
- 10884521076662
- 10884521071766
- 20884521071725
- 10884521071513
Distribution
Distributed nationwide across the United States.
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