The Recall Desk
ModerateFDA (Devices)·Z-1802-2012·Announced 2012-06-20

Vygon Recalls Heparin Lock Flush Syringes and Kits

Vygon is recalling heparin lock flush syringes and kits due to a manufacturer recall of 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 classified as FDA Class II and is described as a voluntary precautionary measure following a manufacturer 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(TM)Flush Heparin Lock Flush Syringes.

The recalled products include the Churchill Medical Systems, Inc. A VYGON Company PICC LINE TRAY Kit, which contains prefilled syringes used to maintain the patency of indwelling catheter lumens. The specific product code is AMS-9848CP-11, and the affected lots are 10J80 and 10K62.

The recall is distributed nationwide, 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. Users should check their inventory for the specific lot numbers and product codes listed above.

The recalled product

Product
Churchill Medical Systems, Inc. A VYGON Company PICC LINE TRAY Kit Prefilled syringes included in the tray 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-9848CP-11 -- lots 10J80 and 10K62.

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 →