The Recall Desk
ModerateFDA (Devices)·Z-1797-2012·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 and related kits. The recall covers nationwide distribution across 23 states.

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 is described as a voluntary recall. The source text does not report any illnesses, injuries, or specific hazards, fitting the criteria for a moderate severity voluntary precautionary recall.

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 that contain these syringes. These prefilled syringes are used to maintain the patency of indwelling catheter lumens.

The affected product is identified by Product Code VIH-4423. The specific lots subject to recall are 92-057-9D, 95-041-9D, 97-063-9D, and 92-155-9D. The product was 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.

The source text does not specify the exact reason for the recall or report any associated illnesses or injuries. Users of these medical devices should check their inventory for the listed product code and lot numbers. If the product matches the recalled items, users should stop using it and contact Vygon Corporation or their medical device supplier for further instructions.

The recalled product

Product
Vygon VY(TM)Flush Heparin Lock Flush Syringes, 1 Unit per mL, 3mL in a 10mL Flush Syringe, 30 syringes per box 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 (4)

  • Product Code VIH-4423 -- lots 92-057-9D
  • 95-041-9D
  • 97-063-9D
  • and 92-155-9D.

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 →