The Recall Desk
ModerateFDA (Devices)·Z-1801-2012·Announced 2012-06-20

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.

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 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
Category
Medical Device — Infusion 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 (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

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 →

Related recalls

Same manufacturer · Vygon Corporation

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Same hazard · voluntary recall

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