Polysorb Suture Recalled for Potential Packaging Integrity Issues
Covidien LLC is recalling Polysorb Braided Absorbable Sutures due to potential packaging integrity issues that may impact the humidity or sterility barrier.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, but the source text describes a potential packaging integrity issue without reporting any specific illnesses, injuries, or hospitalizations. This aligns with the rubric for moderate severity involving low-risk contamination or voluntary precautionary measures where harm has not yet been reported.
Plain-English summary
The U.S. Food and Drug Administration (FDA) has issued a Class II recall for Polysorb Braided Absorbable Suture 6/0 12" VL SS-24 D/A, Item Code L1742K, manufactured by Covidien LLC. The recall involves 139,938 units distributed nationwide in the United States. The specific lot affected is D7H1126X, with an expiration date of August 31, 2022.
The recall was initiated due to a potential for packaging integrity issues that could impact the humidity or sterility barrier of the product. This defect may compromise the sterility of the sutures, which are indicated for use in soft tissue approximation or ligation and ophthalmic surgery, but not in cardiovascular or neural tissue.
Healthcare providers and facilities that have received this product should stop using it and contact the recalling firm for instructions on return or disposal. Consumers should not use this product if they have it in their possession.
The recalled product
- Product
- Polysorb Braided Absorbable Suture 6/0 12"" VL SS-24 D/A, Item Code L1742K - Product Usage: Indicated for use in soft tissue approximation or ligation and ophthalmic surgery, but not in cardiovascular or neural tissue.
- Manufacturer
- Covidien LLC
- Category
- Medical Device — Sutures
- Affected units
- 139,938
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 (1)
- Lot -D7H1126X Expiration Date - 2022-08-31
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 27 recalled by Covidien LLC 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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