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WOM World Of Medicine AG recalls Aquilex Fluid Control System-Intended to provide fluid distension of the uterus during diagnostic and operative hysteros
Recalled October 4, 2023 · FDA recall Z-2629-2023 · WOM World Of Medicine AG
Hazard
The display of inflow volume can reach its limit of 30,000 ml during long procdeure and the inflow volume display will freeze at the maximum value while the deficit will start counting backwards until 0 ml is reached and may result in fluid overload · FDA Class II
Units
1287 units
Sold at
Nationwide Foreign: Canada, Australia, New Zealand, Belgium, France, Germany, Ireland, Netherlands, Spain, Sweden, Norway, Switzerland, UK, Kuwait, Qatar, Turkey, UAE
Description
The display of inflow volume can reach its limit of 30,000 ml during long procdeure and the inflow volume display will freeze at the maximum value while the deficit will start counting backwards until 0 ml is reached and may result in fluid overload
Product
Aquilex Fluid Control System-Intended to provide fluid distension of the uterus during diagnostic and operative hysteroscopies and to monitor the volume differential between the irrigation fluid flowing into and out of the uterus. Models AQL-100PBS and AQL-100P
Manufacturer(s)
WOM World Of Medicine AG
Made in
Germany
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →