Chromic Gut Absorbable Sutures Recalled for Sterilization Failure Risk
Covidien, LP is recalling chromic gut absorbable sutures due to sterilization failure that may leave product unsterile, creating risk of infection or vision loss in eye surgery.
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 with no reported illnesses or injuries. While the hazard of unsterile medical sutures is serious—posing risk of infection and potential vision loss in eye surgery—this is a theoretical risk classification under the rubric criterion for 'risk-of-harm products where injury has not yet been reported.'
Plain-English summary
Covidien, LP is recalling 36,204 units of Chromic Gut Absorbable Sutures across multiple product sizes and catalog numbers. The affected products were distributed nationwide within the United States as well as internationally to Canada, Colombia, El Salvador, Indonesia, Nepal, Puerto Rico, Taiwan, and Thailand.
The recall stems from a supplier calibration issue discovered during the contract sterilization process that may result in affected product being unsterile. Use of unsterile sutures poses a risk of unspecified infection. For sutures used in eye surgery, there is an additional risk of vision loss.
The U.S. Food and Drug Administration has classified this as a Class II recall, indicating a serious issue requiring prompt attention.
The recalled product
- Product
- Chromic Gut Absorbable Sutures, SURGIGUT* 0 CHR GS-25 90CM X36 (CG-904), SURGIGUT* 1 CHR GS-24 90CM X36 (CG-915), CHROMIC GUT 4-0 75CM V20 (GG-121), CHROMIC GUT 3-0 75CM V20 X36 (GG-122), CHROMIC GUT 2-0 75CM V20 X36 (GG-123), CHROMIC GUT 2-0 75CM V26 (GG-127), CHROMIC GUT 4-0 45
- Manufacturer
- Covidien, LP
- Hazard
- unsterile-product
- 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 (12)
- GTIN: 20884521054001
- 20884521054056
- 20884521054889
- 20884521054896
- 20884521054902
- 10884521054905
- 20884521054940
- 20884521055688
- 20884521055770
- 20884521056135
- 10884521056145
- 20884521056142
Distribution
Distributed nationwide across the United States.
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