The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Devices)·Z-1806-2012·Announced 2012-06-20

Vygon Recalls Heparin Lock Flush Syringes and Kits

Vygon is voluntarily recalling Heparin Lock Flush Syringes and kits containing them due to a related recall of VY Flush Heparin Lock Flush Syringes.

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 recall is classified as FDA Class II and is a voluntary precautionary measure initiated in response to a related recall, with no specific injuries or illnesses reported in the source text.

Plain-English summary

Vygon Corporation has initiated a voluntary recall of Vygon branded Heparin Lock Flush Syringes and kits containing these syringes. This action follows a voluntary recall issued by the manufacturer for multiple lots of VY Flush Heparin Lock Flush Syringes.

The affected products include the Churchill Medical Systems, Inc. VAD ACCESS TRAY Kit, which contains prefilled syringes used to maintain the patency of indwelling catheter lumens. The recall covers specific product code AMS-9437CP and lots 1112059, 1112106, 1202101, 1101505, 1101026, 1103020, 1104130, 1103190, and 1109064.

The 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 discontinue use if found.

The recalled product

Product
Churchill Medical Systems, Inc. VAD ACCESS TRAY Kit Prefilled syringes included in the kit are used to maintain the patency of indwelling catheter lumens
Manufacturer
Vygon Corporation
Category
Medical Device — Syringes and Infusion Accessories
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 (9)

  • Product Code AMS-9437CP -- lots 1112059
  • 1112106
  • 1202101
  • 1101505
  • 1101026
  • 1103020
  • 1104130
  • 1103190
  • and 1109064.

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 →

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