Vygon Recalls Heparin Lock Flush Syringes Due to Voluntary Manufacturer Action
Vygon Corporation is voluntarily recalling multiple lots of VY Flush Heparin Lock Flush Syringes and related kits 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 explicitly describes this as a 'voluntary recall' initiated by the manufacturer. According to the rubric, voluntary precautionary recalls without reported injuries or specific high-risk pathogens are classified as Moderate.
Plain-English summary
Vygon Corporation has initiated a voluntary recall of multiple lots of VY Flush Heparin Lock Flush Syringes. The recall also includes Vygon-branded Heparin Lock Flush Syringes and kits containing these syringes. These prefilled syringes are used to maintain the patency of indwelling catheter lumens.
The recall covers specific product codes and lots, including Product Code VIH-3335. The affected lots include 89-099-9D, 89-143-9D, 90-093-9D, 92-073-9D, 92-097-9D, 92-124-9D, 92-140-9D, 92-142-9D, 94-009-9D, 94-013-9D, 94-045-9D, 94-140-9D, 94-147-9D, 95-013-9D, 95-014-9D, 95-109-9D, 96-049-9D, 98-010-9D, 99-041-9D, 00-012-9D, 01-036-9D, 01-055-9D, 02-065-9D, 02-067-9D, 02-100-9D, 07-020-9D, 07-031-9D, 07-033-9D, 07-041-9D, 08-037-9D, 08-048-9D, 09-007-9D, 09-009-9D, 09-022-9D, 10-001-9D, 10-012-9D, 10-049-9D, 10-039-9D, 12-022-9D, and 12-026-9D.
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 if found.
The recalled product
- Product
- Vygon VY(TM)Flush Heparin Lock Flush Syringes, 100 Units per mL, 5mL 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
- 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 (20)
- Product Code VIH-3335 -- lots 89-099-9D
- 89-143-9D
- 90-093-9D
- 92-073-9D
- 92-097-9D
- 92-124-9D
- 92-140-9D
- 92-142-9D
- 94-009-9D
- 94-013-9D
- 94-045-9D
- 94-140-9D
- 94-147-9D
- 95-013-9D
- 95-014-9D
- 95-109-9D
- 96-049-9D
- 98-010-9D
- 99-041-9D
- 00-012-9D
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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