Medical device recalls Moderate risk

WOM World of Medicine AG recalls Aquilex Fluid Control System component: Bag deflector, REF AQL-100CBS Product Usage: Distends uterus with fluid during…

Recall date
August 14, 2019
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-2767-2019
FDA classification
Class II
Brand / firm
WOM World of Medicine AG
Sold / distributed
US Nationwide Distribution

Why it was recalled

The deficit displayed by the pump can differ from the real deficit, leading potentially to patient risk.

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

What was recalled

Aquilex Fluid Control System component: Bag deflector, REF AQL-100CBS Product Usage: Distends uterus with fluid during diagnostic and operative hysteroscopies.

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