Agency classClass IIOur severity:Moderate FDA (Devices)·Z-1804-2012·Announced 2012-06-20

Vygon Recalls Heparin Lock Flush Syringes and PICC Insertion Kits

Vygon is recalling heparin lock flush syringes and kits containing them due to a voluntary 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, but the source text does not report any hospitalizations, injuries, or specific high-risk pathogens, fitting the criteria for a moderate severity voluntary precautionary recall.

Plain-English summary

Vygon Corporation has initiated a 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(TM)Flush Heparin Lock Flush Syringes.

The recalled products include the Churchill Medical Systems, Inc. A VYGON Company PICC INSERTION TRAY Kit. These kits contain prefilled syringes used to maintain the patency of indwelling catheter lumens. The specific product code is AMS-8280CP-4, and the affected lots are 10K16, 10L20, 11A78, 11B24, 11B16, 11C70, and 11D14.

The recall is 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 nature of the defect or any reported injuries.

The recalled product

Product: Churchill Medical Systems, Inc. A VYGON Company PICC INSERTION TRAY Kit Prefilled syringes included in the kit are used to maintain the patency of indwelling catheter lumens
Manufacturer: Vygon Corporation
Category: Medical Device — Infusion Supplies
Hazard: contamination
defect

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 (7)

Product Code AMS-8280CP-4 -- lots 10K16
10L20
11A78
11B24
11B16
11C70
and 11D14.

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
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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 Due to Voluntary Manufacturer Action
FDA (Devices) · 2012-06-20

Same hazard · contamination