FDA Recalls Polysorb Sutures Due to Potential Packaging Integrity Issues
The FDA is recalling specific lots of Polysorb Braided Absorbable Sutures due to potential packaging integrity issues that could 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, which typically corresponds to a Moderate severity score (2) when no specific injuries or illnesses are reported in the source text, and the hazard is a potential packaging integrity issue.
Plain-English summary
The U.S. Food and Drug Administration (FDA) is recalling specific production lots of Polysorb Braided Absorbable Suture 2-0 UNDYED 36" GS-21, Item Code CL953, manufactured by Covidien LLC. The recall is initiated due to a potential for packaging integrity issues that may impact the humidity or sterility barrier of the product.
The affected product is indicated for use in soft tissue approximation or ligation and ophthalmic surgery, but is not indicated for use in cardiovascular or neural tissue. The recall involves 139,938 units distributed nationwide in the United States. The specific lot number is A9K0004Y, with an expiration date of September 30, 2024.
Healthcare providers and facilities should check their inventory for this specific lot number and stop using the product if found. The FDA classifies this as a Class II recall, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
The recalled product
- Product
- Polysorb Braided Absorbable Suture 2-0 UNDYED 36" GS-21, Item Code CL953 - 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 - A9K0004Y Expiration Date - 2024-09-30
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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