Surgical sutures recalled due to substandard gamma sterilization doses
Covidien is recalling multiple surgical suture products because certain lots were sterilized with gamma doses exceeding approved levels. The excess radiation may reduce suture strength over time, potentially causing wound failure and bleeding.
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 of high-risk surgical products where sterilization defect may reduce strength. While no illnesses have been reported and the hazard is theoretical, suture failure during critical surgery poses significant injury risk, meeting the criteria for Score 3: risk-of-harm products where injury has not yet been reported.
Plain-English summary
Covidien LP is recalling specific lots of surgical sutures, including Sofsilk Braided Silk sutures, Ti-Cron Coated Braided Polyester sutures, Monosof Monofilament Nylon sutures, and Steel Monofilament Stainless Steel sutures. The recall affects 46,812 units in the United States and 68,976 units internationally, distributed worldwide.
The affected sutures were sterilized using gamma radiation at doses that exceeded the FDA-approved range. The manufacturer states that excessive gamma exposure may gradually decrease the tensile strength of the sutures over time.
If suture strength is reduced, potential complications could include wound dehiscence (opening of surgical wounds) and hemorrhage or significant bleeding during or after surgery. No illnesses or injuries have been reported to date.
Healthcare facilities that have received affected lots should identify and quarantine the products using the lot numbers provided in the FDA recall notice and consult with Covidien for replacement supplies.
The recalled product
- Product
- Sofsilk Braided Silk sutures: CS-211 SOFSILK* 4-0 BLK 45CM CVF21 X36 GS-831 SOFSILK* 4-0 BLK 75CM V20 X36 S-176 SOFSILK* 0 BLK 12X45CM PCT X24 S-182 SOFSILK* 5-0 BLK 12X45CM PCT X36 S-184 SOFSILK* 3-0 BLK 12X45CM PCT X36 S-185 SOFSILK* 2-0 BLK 12X45CM PCT X36 S-245 SOFSILK* 2-0
- Manufacturer
- Covidien LP
- Hazard
- sterilization-defect
- reduced-strength
- wound-dehiscence
- hemorrhage
Distribution
Distributed nationwide across the United States.
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