FDA Recalls Polysorb Sutures Due to Packaging Integrity Issues
The FDA is recalling specific lots of Polysorb Braided Absorbable Sutures due to potential packaging integrity issues that could compromise 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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II, which corresponds to a 'Severe' rating under the rubric, particularly given the risk of sterility compromise in a surgical device.
Plain-English summary
The U.S. Food and Drug Administration (FDA) has issued a Class II recall for Polysorb Braided Absorbable Suture 1 30 VIOLET GS-22, Item Code CL885, manufactured by Covidien LLC. The recall involves 139,938 units distributed nationwide in the United States. The specific lot affected is A9H1065Y, with an expiration date of July 31, 2024.
The recall was initiated due to potential packaging integrity issues that may impact the humidity or sterility barrier of the product. This defect could potentially compromise the sterility of the sutures, which are indicated for use in soft tissue approximation, 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 manufacturer or disposed of according to local regulations. No specific instructions for consumers are provided as this is a medical device intended for professional use.
The recalled product
- Product
- Polysorb Braided Absorbable Suture 1 30 VIOLET GS-22, Item Code CL885 - 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 - A9H1065Y 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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