Vygon DUALSTOP White Caps Recalled for Defect Causing Leaks
Vygon U.S.A. is recalling Vyon DUALSTOP White Caps used for intravascular lines because a defect causes leaks in the affected product.
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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device defect causing leaks in intravascular lines, which poses a risk of harm, but the source text does not report any specific injuries or illnesses.
Plain-English summary
Vygon U.S.A. is recalling Vyon DUALSTOP White Caps used for intravascular lines. The recall is being conducted because a defect in the product causes leaks. The affected product code is 9888.002.
The recall covers 107,700 units distributed nationwide in the United States. The affected lot codes are 090718FD, 250118FD, 081117FD, 130218FD, 050418FD, and 020518FD.
Healthcare facilities and consumers should stop using the affected caps and contact Vygon U.S.A. for instructions on how to return the product or obtain a replacement.
The recalled product
- Product
- Vyon DUALSTOP White Cap used for intravascular lines Product Code: 9888.002- Product Usage: Cap used for intravascular lines.
- Manufacturer
- Vygon U.S.A.
- Hazard
- Affected units
- 107,700
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)
- Lot codes: 090718FD 250118FD 081117FD 130218FD 050418FD 020518FD
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 recalled by Vygon U.S.A. 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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