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 similar syringes by the manufacturer.
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 action initiated in response to a manufacturer recall, with no specific injuries or illnesses reported in the source text.
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 of VY(TM)Flush Heparin Lock Flush Syringes.
The affected products include the Churchill Medical Systems, Inc. A VYGON COMPANY PICC Insertion Tray, which contains prefilled syringes used to maintain the patency of indwelling catheter lumens. The recall covers specific lots of product code AMS-8172CP-5, including lots 10J15, 10K09, 10K19, 11A77, 11C103, 11D79, 11F66, 11H18, 11J41, and 11L54.
These products were 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. Healthcare facilities and consumers should stop using the affected lots and contact Vygon Corporation for further instructions.
The recalled product
- Product
- Churchill Medical Systems, Inc. A VYGON COMPANY PICC INSERTION TRAY 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 (10)
- Product Code AMS-8172CP-5 -- lots 10J15
- 10K09
- 10K19
- 11A77
- 11C103
- 11D79
- 11F66
- 11H18
- 11J41
- and 11L54.
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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