Chromic Gut Absorbable Sutures recalled due to sterilization failure
Covidien is recalling Chromic Gut Absorbable Sutures due to a sterilization process failure that may result in unsterile product. Use of affected sutures may cause infection or, in eye surgery, vision loss.
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 classification combined with a sterilization failure resulting in unsterile product poses a risk of infection and potential vision loss in ocular surgery. This is a risk-of-harm product where injury has not been reported, meeting the criteria for High severity.
Plain-English summary
Covidien, LP is recalling specific lot numbers (D2H0095ZY and D2H0096ZY) of Chromic Gut Absorbable Sutures. A total of 960 units are affected, including model CH GUT 5-0 and CHROMIC GUT 6-0 sutures.
A calibration issue was identified during the contract sterilization process that may result in unsterile product. Use of affected sutures may lead to unspecified infection. When sutures are used in eye surgery, there is a risk of vision loss.
The affected sutures were distributed worldwide to the United States (Arkansas, California, Florida, Georgia, Louisiana, Massachusetts, North Carolina, New York, Ohio, and Washington) and internationally to Canada, Colombia, El Salvador, Indonesia, Nepal, Puerto Rico, Taiwan, and Thailand.
The recalled product
- Product
- Mild Chromic Gut Absorbable Sutures, CH GUT 5-0 12 UD SS-14 SS-14 (G-1766-K), CHROMIC GUT 6-0 45CM HE-1 X12 (G-1780K)
- Manufacturer
- Covidien, LP
- Category
- Medical Device
- Affected units
- 960
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 (4)
- GTIN: 20884521054339
- 20884521054438
- Lot: D2H0095ZY
- D2H0096ZY
Distribution
Part of a larger recall action
This product is one of 4 recalled by Covidien, LP under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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