Polysorb Suture Recall Due to Packaging Integrity Issues
Covidien LLC is recalling specific lots of Polysorb Braided Absorbable Suture due to potential packaging integrity issues that may impact sterility.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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 is a risk-of-harm product where injury has not yet been reported.
Plain-English summary
The U.S. Food and Drug Administration (FDA) has issued a Class II recall for Polysorb Braided Absorbable Suture 0 30" UNDYED HOS-11, Item Code CL537, manufactured by Covidien LLC. The recall involves 139,938 units distributed nationwide in the United States. The specific lot affected is A9J0018Y, with an expiration date of August 31, 2024.
The recall was initiated due to a potential for packaging integrity issues that could impact the humidity or sterility barrier of the product. This defect poses a risk to the sterility of the suture, which is indicated for use in soft tissue approximation, ligation, and ophthalmic surgery, but not in cardiovascular or neural tissue.
Healthcare facilities and distributors 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 surgical settings.
The recalled product
- Product
- Polysorb Braided Absorbable Suture 0 30" UNDYED HOS-11, Item Code CL537 - 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 - A9J0018Y 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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