The Recall Desk
ModerateFDA (Devices)·Z-1805-2012·Announced 2012-06-20

Vygon Recalls Heparin Lock Flush Syringes and Kits

Vygon Corporation is recalling Heparin Lock Flush Syringes and kits due to a voluntary recall of related VY Flush Heparin Lock Flush Syringes.

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 a voluntary precautionary action initiated in response to a related product recall, with no reported illnesses or injuries in the source text.

Plain-English summary

Vygon Corporation is voluntarily recalling its branded Heparin Lock Flush Syringes and kits that contain 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 specific product code is AMS-8522CP-3, lot 10K50. The recall covers nationwide distribution, including 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.

Consumers and healthcare facilities should stop using the recalled products and contact Vygon Corporation for further instructions or a replacement.

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

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 (1)

  • Product Code AMS-8522CP-3 - lot 10K50.

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 →