FDA Recalls Polysorb Sutures Due to Packaging Integrity Concerns
The FDA is recalling specific lots of Polysorb Braided Absorbable Sutures due to potential packaging integrity issues that could compromise 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 involves a risk-of-harm product (sterile medical device) where injury has not yet been reported, fitting the criteria for a High severity score.
Plain-English summary
The U.S. Food and Drug Administration (FDA) is recalling specific production lots of Polysorb Braided Absorbable Suture 2/0 30 VIOLET GS-21, Item Code CL811, manufactured by Covidien LLC. The recall involves 139,938 units distributed nationwide in the United States. The specific lot number is A9J0075Y, with an expiration date of August 31, 2024.
The recall was initiated due to a potential for 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 or ligation and ophthalmic surgery, but not in cardiovascular or neural tissue.
Healthcare providers and facilities should check their inventory for this specific lot number and stop using the affected units. Consumers are not expected to have these products in their homes, as they are medical devices intended for professional use.
The recalled product
- Product
- Polysorb Braided Absorbable Suture 2/0 30 VIOLET GS-21, Item Code CL811 - 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 (1)
- Lot - A9J0075Y 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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