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WOM World of Medicine AG recalls Covidien HysteroLux Fluid Management System Control Unit, REF: 72205000
Recalled October 6, 2021 · FDA recall Z-2561-2021 · WOM World of Medicine AG
Hazard
When the display of inflow volume to the uterus reaches 32450 ml, the fluid management system control unit display will freeze because the internal software calculation threshold is reached. The outflow measurement will continue, and so the deficit accumulated up to this point will start counting backwards to 0 ml. There is a risk of distention fluid reaching the soft tissue circulatory system. · FDA Class II
Units
1100
Sold at
US Nationwide distribution in the state of CT.
Description
When the display of inflow volume to the uterus reaches 32450 ml, the fluid management system control unit display will freeze because the internal software calculation threshold is reached. The outflow measurement will continue, and so the deficit accumulated up to this point will start counting backwards to 0 ml. There is a risk of distention fluid reaching the soft tissue circulatory system.
Product
Covidien HysteroLux Fluid Management System Control Unit, REF: 72205000
Manufacturer(s)
WOM World of Medicine AG
Made in
Germany
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →