Polysorb Suture Recalled for Potential Packaging Integrity Issues
Covidien LLC is recalling specific lots of Polysorb Braided Absorbable Suture 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, and the source text describes a potential packaging integrity issue without reporting any specific illnesses, injuries, or hospitalizations, fitting the criteria for a moderate severity precautionary recall.
Plain-English summary
The U.S. Food and Drug Administration has identified a recall for Polysorb Braided Absorbable Suture 2/0 30" VIOLET GU-46, Item Code UL878, manufactured by Covidien LLC. The recall involves 139,938 units distributed nationwide in the United States. The specific lot affected is D7H0866X, with an expiration date of August 31, 2022.
The recall is being conducted because there is a potential for packaging integrity issues that could impact the humidity or sterility barrier of the product. The suture is indicated for use in soft tissue approximation or ligation and ophthalmic surgery, but is not intended for use in cardiovascular or neural tissue.
Healthcare providers and facilities should check their inventory for the specific lot number and expiration date listed above. If the product is found, it should be removed from use and returned to the distributor or manufacturer in accordance with standard recall procedures.
The recalled product
- Product
- Polysorb Braided Absorbable Suture 2/0 30"VIOLET GU-46, Item Code UL878 - 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 — Surgical Suture
- 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 - D7H0866X 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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