FDA-Device2021-10-06Class II
Covidien HysteroLux Fluid Management System Control Unit, REF: 72205000
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.
Sold states
US Nationwide distribution in the state of CT.
Affected count
1100
Manufactured in
Salzufer 8, N/A, Berlin, N/A, Germany
Products
Covidien HysteroLux Fluid Management System Control Unit, REF: 72205000
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2561-2021Don't want to check this manually?
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