Sofsilk Coated Braided Silk Sutures recalled for sterile barrier breach
Covidien is recalling Sofsilk Coated Braided Silk Sutures due to a sterile barrier breach in the breather pouch. The breach may cause infection or vision loss during ophthalmic procedures involving direct patient contact.
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 medical device with a documented sterile barrier defect in a surgical product used in ophthalmic procedures, posing a risk of contamination and harm. No illnesses or injuries have been reported.
Plain-English summary
Covidien, LP is recalling multiple lots of Sofsilk Coated Braided Silk Sutures distributed in the United States and internationally. Approximately 271,800 units are affected across various product configurations and gauges.
The recalled sutures have a sterile barrier breach in the breather pouch, the component designed to maintain sterility. A compromised sterile barrier risks contamination of the surgical sutures.
The breach may result in infection or vision loss when sutures are used in ophthalmic (eye) procedures involving direct patient contact. No illnesses or injuries have been reported to date. Healthcare providers should verify whether they have affected lot numbers and contact Covidien regarding appropriate measures.
The recalled product
- Product
- Sofsilk Coated Braided Silk Suture Product Description CS-211 SOFSILK* 4-0 BLK 45CM CVF21 X36 CS211 CS-490 SOFSILK* 2-0 BLK 75CM GS11 X36 CS490 CS-562 SOFSILK* 2-0 BLK 75CM GS23 X36 CS562 GS-823 SOFSILK* 2-0 BLK 75CM V30 X36 GS823 GS-835 SOFSILK* 1 BLK 75CM V20 X36
- Manufacturer
- Covidien, LP
- Category
- Medical Device — Surgical Suture
- Hazard
- sterile-barrier-breach
- 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 (20)
- GTIN: 20884521086781
- 20884521758060
- 20884521088136
- 20884521088525
- 20884521087504
- 20884521085289
- 20884521087672
- 20884521087481
- 20884521090566
- 20884521086712
- 20612479214235
- 10884521084698
- 20884521084695
- 20884521085166
- 20884521087580
- 10884521087583
- 20884521089256
- 20884521088532
- 20884521087719
- 20884521090160
Distribution
Distributed nationwide across the United States.
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