Vygon DUALSTOP Red Caps Recalled for Defects Causing Leaks
Vygon U.S.A. is recalling 339,800 DUALSTOP Red Caps used for intravascular lines because a defect causes leaks.
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 defect in a medical device used for intravascular lines that causes leaks. This presents a risk of harm (such as infection or fluid loss) where injury has not yet been reported, fitting the criteria for a High severity score.
Plain-English summary
Vygon U.S.A. is recalling 339,800 units of Vygon DUALSTOP Red Caps (Product Code 9888.00) used for intravascular lines. The recall is due to a defect in the caps that causes leaks in the affected product.
The affected products were distributed nationwide in the United States. The recall includes specific lot codes: 310518FD, 050618FD, 140318FD, 160617FD, 200917FD, 061117FD, 090118FD, 200218FD, 290318FD, and 110418FD.
Healthcare providers and consumers should stop using the affected caps and contact Vygon U.S.A. for further instructions or a replacement.
The recalled product
- Product
- Vygon DUALSTOP Red Cap used for intravascular lines Product Code: 9888.00 - Product Usage: Cap used for intravascular lines.
- Manufacturer
- Vygon U.S.A.
- Hazard
- Affected units
- 339,800
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.
See all 2 products in this recall →Related recalls
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