FDA recall Z-2561-2021

WOM World of Medicine AG · Class II · device

Product

Covidien HysteroLux Fluid Management System Control Unit, REF: 72205000

Reason for recall

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.

Distribution

US Nationwide distribution in the state of CT.

Key facts

Status
Ongoing
Initiation date
2021-06-18
Report date
2021-10-06
Voluntary/Mandated
Voluntary: Firm initiated
Location
Berlin, N/A, Germany

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2561-2021