FDA Recalls Polysorb Sutures Due to Packaging Integrity Issues
The FDA is recalling specific lots of Polysorb Braided Absorbable Sutures due to potential packaging integrity issues that may compromise sterility.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
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, which typically involves a temporary or medically reversible adverse health consequence. The hazard is a potential packaging integrity issue affecting sterility, which is a significant but not immediate critical risk, fitting the Moderate category for precautionary recalls without reported injuries.
Plain-English summary
The U.S. Food and Drug Administration (FDA) has issued a recall for Polysorb Braided Absorbable Suture 4/0 30 VIOLET CVF23, Item Code UL203, manufactured by Covidien LLC. The recall involves 139,938 units distributed nationwide in the United States.
The recall is being conducted because there is a potential for packaging integrity issues that could impact the humidity or sterility barrier of specific production lots. The affected lots are D7G2301X (expiration date 2022-07-31) and D7H0092X (expiration date 2022-08-31). The product is indicated for use in soft tissue approximation or ligation and ophthalmic surgery, but not in cardiovascular or neural tissue.
Healthcare facilities and distributors should check their inventory for these specific lot numbers and stop using the affected products. Consumers should not use these sutures if they have them in their possession.
The recalled product
- Product
- Polysorb Braided Absorbable Suture 4/0 30 VIOLET CVF23, Item Code UL203 - 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 (2)
- 1) Lot - D7G2301X Expiration Date - 2022-07-31
- 2) Lot - D7H0092X 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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