FDA Recalls Polysorb Sutures Due to Potential Sterility Barrier Issues
The FDA is recalling specific lots of Polysorb Braided Absorbable Sutures due to potential packaging integrity issues that could compromise the sterility barrier.
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 2/5 (Moderate).
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, and the source text describes a potential packaging integrity issue without reporting any specific illnesses or injuries, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
The U.S. Food and Drug Administration (FDA) has issued a Class II recall for Polysorb Braided Absorbable Suture 2/0 UNDYED 30" V-30 (75CM), Item Code GL228, manufactured by Covidien LLC. The recall affects 139,938 units distributed nationwide in the United States. The specific lot number is D7H0794X, with an expiration date of August 31, 2022.
The recall was initiated because there is a potential for packaging integrity issues that could 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 facilities and distributors should check their inventory for the affected lot number and stop using the product if it matches the recalled description. The FDA classifies this as a Class II recall, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- Polysorb Braided Absorbable Suture 2/0 UNDYED 30" V-30 (75CM), Item Code GL228 - 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 - D7H0794X Expiration Date - 2022-08-31
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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