FDA-Device2019-10-09Class II
Aquilex Fluid Control System component: Bag deflector, REF AQL-100CBS Product Usage: Distends uterus with fluid during diagnostic and operative hysteroscopies.
WOM World of Medicine AG
Hazard
The deficit displayed by the pump can differ from the real deficit, leading potentially to patient risk.
Sold states
US Nationwide Distribution
Affected count
322 units
Manufactured in
Salzufer 8, N/A, Berlin, N/A, Germany
Products
Aquilex Fluid Control System component: Bag deflector, REF AQL-100CBS Product Usage: Distends uterus with fluid during diagnostic and operative hysteroscopies.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2767-2019Don't want to check this manually?
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