FDA Recalls Polysorb Sutures Due to Packaging Integrity Concerns
The FDA is recalling specific lots of Polysorb Braided Absorbable Sutures due to potential packaging integrity issues that could compromise the 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 illnesses or injuries, fitting the criteria for a moderate severity precautionary recall.
Plain-English summary
The U.S. Food and Drug Administration (FDA) is recalling specific production lots of Polysorb Braided Absorbable Suture 2-0 VIOLET 36" GS-21, Item Code CL923, manufactured by Covidien LLC. 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 affected product is indicated for use in soft tissue approximation or ligation and ophthalmic surgery, but is not intended for use in cardiovascular or neural tissue. The recall covers 139,938 units distributed nationwide in the United States. The specific lots involved are A9H1189Y (expiration date 2024-07-31) and A9J0345Y (expiration date 2024-08-31).
Healthcare facilities and distributors should stop using the affected lots and follow the instructions provided by the recalling firm, Covidien LLC, for return or disposal. Patients who have had surgery using these specific lots should contact their healthcare provider if they have concerns about the integrity of the suture packaging.
The recalled product
- Product
- Polysorb Braided Absorbable Suture 2-0 VIOLET 36" GS-21, Item Code CL923 - Product Usage: Indicated for use in soft tissue approximation or ligation and ophthalmic surgery, but not in cardiovascular or neural tissue.
- Manufacturer
- Covidien LLC
- 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 - A9H1189Y Expiration Date - 2024-07-31
- 2) Lot - A9J0345Y Expiration Date - 2024-08-31
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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