Medical device recalls Moderate risk

Vygon U.S.A. recalls Vygon DUALSTOP Red Cap used for intravascular lines Product Code: 9888.00 - Product Usage: Cap used for intravascular l…

Recall date
December 6, 2018
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-1114-2019
FDA classification
Class II
Brand / firm
Vygon U.S.A.
Sold / distributed
US Nationwide distribution.

Why it was recalled

DualStop Caps defect causing leaks in affected product

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Vygon DUALSTOP Red Cap used for intravascular lines Product Code: 9888.00 - Product Usage: Cap used for intravascular lines.

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