Recall of Polysorb Braided Absorbable Suture Due to Packaging Integrity Issues
Covidien LLC is recalling specific lots of Polysorb Braided Absorbable Suture 13-0 due to potential packaging integrity issues that may impact sterility.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves a potential loss of sterility in a medical device used in surgery, which poses a risk of harm even though no specific injuries are reported in the source text.
Plain-English summary
The U.S. Food and Drug Administration (FDA) has issued a Class II recall for Polysorb Braided Absorbable Suture 13-0 VIOLET 30" GS-23, Item Code CL892, 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 A9J0006Y, with an expiration date of August 31, 2024. The product is indicated for use in soft tissue approximation or ligation and ophthalmic surgery, but not in cardiovascular or neural tissue.
Healthcare providers and facilities should check their inventory for the specific lot number and expiration date listed above. If the product is found, it should be removed from use and returned to the supplier or manufacturer in accordance with recall instructions.
The recalled product
- Product
- Polysorb Braided Absorbable Suture 13-0 VIOLET 30" GS-23, Item Code CL892 - 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 — Surgical Suture
- 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 - A9J0006Y 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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