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.
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, 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
- 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 (7)
- Product Code AMS-8280CP-4 -- lots 10K16
- 10L20
- 11A78
- 11B24
- 11B16
- 11C70
- and 11D14.
Distribution
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.
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