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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