Polysorb Braided Absorbable Suture Recalled for 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. This aligns with the rubric for moderate severity, representing a risk of harm where injury has not yet been reported or a voluntary precautionary measure.
Plain-English summary
The U.S. Food and Drug Administration (FDA) has issued a Class II recall for Polysorb Braided Absorbable Suture 0 36 VIOLET GS-24, Item Code CL914, manufactured by Covidien LLC. The recall affects 139,938 units distributed nationwide in the United States. The specific lots involved are A9H1186Y (expiration date 2024-07-31) and A9J0015Y (expiration date 2024-08-31).
The recall was initiated because there is a potential for packaging integrity issues that could impact the humidity or sterility barrier of the product. This 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.
Healthcare providers and facilities should check their inventory for the affected lot numbers and expiration dates. If the product is found, it should be removed from use and returned to the manufacturer or disposed of according to local regulations. Patients who have already received this product should contact their healthcare provider if they have concerns.
The recalled product
- Product
- Polysorb Braided Absorbable Suture 0 36 VIOLET GS-24, Item Code CL914 - 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 - A9H1186Y Expiration Date - 2024-07-31
- 2) Lot A9J0015Y 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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