The Recall Desk
ModerateFDA (Devices)·Z-1800-2012·Announced 2012-06-20

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.

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 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

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

Distributed nationwide across the United States.

The notice also names 23 states specifically:

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.

See all 12 products in this recall →