Vygon Recalls Heparin Lock Flush Syringes and Dressing Change Kits
Vygon Corporation is voluntarily recalling Heparin Lock Flush Syringes and kits containing them due to a related 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 a voluntary precautionary measure initiated in response to a related product recall, with no specific injuries, illnesses, or FDA Class I classification 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 manufacturer-issued voluntary recall of multiple lots of VY Flush Heparin Lock Flush Syringes. The recalled products include the Churchill Medical Systems, Inc. Dressing Change Kit, which contains prefilled syringes used to maintain the patency of indwelling catheter lumens.
The recall is limited to Product Code AMS-7091CP, Lot 11C119. The affected 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 syringes and kits and contact Vygon Corporation for further instructions or a replacement.
The recalled product
- Product
- Churchill Medical Systems, Inc. DRESSING CHANGE KIT 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 (1)
- Product Code AMS-7091CP - lot 11C119.
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.
See all 12 products in this recall →Related recalls
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