Polysorb Suture Recall Due to Packaging Integrity Issues
Covidien LLC is recalling Polysorb Braided Absorbable Sutures due to potential packaging integrity issues that may impact sterility.
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 hazard is a potential packaging integrity issue affecting sterility without reported injuries or illnesses, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
The U.S. Food and Drug Administration (FDA) has issued a Class II recall for Polysorb Braided Absorbable Suture 3/0 30 VIOLET GS-11, Item Code CL815, 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 lot is A9H1170Y with an expiration date of July 31, 2024. The 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 stop using the affected product and contact the recalling firm for further instructions. Consumers are not directly affected as this is a medical device used in clinical settings.
The recalled product
- Product
- Polysorb Braided Absorbable Suture 3/0 30 VIOLET GS-11, Item Code CL815 - 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 (1)
- Lot - A9H1170Y Expiration Date - 2024-07-31
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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