Agency classClass IIOur severity:Moderate FDA (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.

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 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
Category: Medical Device — Syringes and Infusion Kits
Hazard: contamination
mis-labeling

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 →

Same manufacturer · Vygon Corporation

See all →

High
Vygon Recalls Bionector Needleless Connectors Due to Membrane Elasticity Issues
FDA (Devices) · 2014-10-29
Moderate
Vygon Recalls 210 CT PICC Kits Packaged with Incorrect Needles
FDA (Devices) · 2013-03-20
Moderate
Vygon Recalls Heparin Lock Flush Syringes Due to Voluntary Manufacturer Action
FDA (Devices) · 2012-06-20
Moderate
Vygon Recalls Heparin Lock Flush Syringes Due to Voluntary Manufacturer Action
FDA (Devices) · 2012-06-20
Moderate
Vygon Recalls Heparin Lock Flush Syringes and PICC Insertion Kits
FDA (Devices) · 2012-06-20

Same hazard · contamination