Biosyn Monofilament Absorbable Suture Recalled for Packaging Integrity Issues
FDA is recalling Biosyn Monofilament Absorbable Suture 6/0 30" VIOLET CV-23 due to potential packaging integrity issues that may impact the humidity or 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, and the source text describes a potential packaging integrity issue without reporting any illnesses or injuries, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
The U.S. Food and Drug Administration (FDA) is recalling Biosyn Monofilament Absorbable Suture 6/0 30" VIOLET CV-23, Item Code UM201, manufactured by Covidien LLC. The recall involves 139,938 units distributed nationwide in the United States. The specific lot affected is D7H0404X, 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 specific production lots. This defect may compromise the sterility of the medical device.
Healthcare providers and facilities should check their inventory for the specific lot number D7H0404X and stop using the affected sutures. Consumers should not use these products and should contact their healthcare provider or the manufacturer for further instructions.
The recalled product
- Product
- Biosyn Monofilament Absorbable Suture 6/0 30" VIOLET CV-23, Item Code UM201
- 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 - D7H0404X 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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