FDA Recalls Polysorb Braided Absorbable Sutures Due to Packaging Integrity Issues
The FDA is recalling specific lots of Polysorb Braided Absorbable Sutures due to potential packaging integrity issues that may compromise the sterility barrier.
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, which typically corresponds to a moderate severity level where the hazard is unlikely to cause serious adverse health consequences but may cause temporary or medically reversible harm.
Plain-English summary
The U.S. Food and Drug Administration (FDA) is recalling specific production lots of Polysorb Braided Absorbable Suture 0 VIOLET 30" V-20, Item Code GL124, manufactured by Covidien LLC. The recall is due to potential packaging integrity issues that may impact the humidity or sterility barrier of the product.
The affected 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. The recall covers 139,938 units distributed nationwide in the United States. The specific lot number is A9J0053Y, with an expiration date of August 31, 2024.
Healthcare providers and facilities should check their inventory for this specific lot number and stop using the product if found. The FDA classifies this as a Class II recall, indicating a reasonable probability that the use of the product could cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- Polysorb Braided Absorbable Suture 0 VIOLET 30" V-20, Item Code GL124 - 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 - A9J0053Y 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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