Vygon Recalls Heparin Lock Flush Syringes Due to Voluntary Manufacturer Action
Vygon Corporation is voluntarily recalling specific lots of VY Flush Heparin Lock Flush Syringes. The recall covers syringes and kits distributed nationwide.
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 source text describes a voluntary recall without reporting any illnesses, injuries, or specific defects, which aligns with the rubric criteria for voluntary precautionary recalls.
Plain-English summary
Vygon Corporation has initiated a voluntary recall of multiple lots of VY Flush Heparin Lock Flush Syringes. The recall includes the syringes themselves as well as kits containing these syringes. The product is a prescription-only medical device used to maintain the patency of indwelling catheter lumens.
The recall affects specific product code VIH-3333 and includes lots 91-036-9D, 92-079-9D, 97-040-9D, 99-130-9D, 01-005-9D, 01-062-9D, 01-063-9D, 03-082-9D, 07-046-9D, 08-060-9D, 95-070-9D, 96-006-9D, 94-010-9D, and 10-010-9D. The source text does not specify the exact reason for the recall or report any illnesses or injuries.
The affected products were distributed nationwide, including in Arizona, California, Delaware, Florida, Illinois, Indiana, Iowa, Kansas, Kentucky, Maryland, Massachusetts, Michigan, Minnesota, Missouri, New Jersey, New York, Ohio, Pennsylvania, Utah, Virginia, Washington, West Virginia, and Wisconsin. Healthcare facilities and consumers should check their inventory for these specific lot numbers and stop using the affected products.
The recalled product
- Product
- Vygon VY(TM)Flush Heparin Lock Flush Syringes, 100 Units per mL, 3mL in a 10mL Flush Syringe, 30 syringes per box, Rx only Prefilled syringes are used to maintain the patency of indwelling catheter lumens
- Manufacturer
- Vygon Corporation
- Category
- Medical Device — Syringes
- Hazard
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 (14)
- Product Code VIH-3333 -- lots 91-036-9D
- 92-079-9D
- 97-040-9D
- 99-130-9D
- 01-005-9D
- 01-062-9D
- 01-063-9D
- 03-082-9D
- 07-046-9D
- 08-060-9D
- 95-070-9D
- 96-006-9D
- 94-010-9D
- and 10-010-9D.
Distribution
Part of a larger recall action
This product is one of 12 recalled by Vygon Corporation 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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