WOM World of Medicine AG recalls Covidien HysteroLux Fluid Management System Control Unit, REF: 72205000

Recall date

June 18, 2021

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-2561-2021

FDA classification

Class II

Brand / firm

WOM World of Medicine AG

Sold / distributed

US Nationwide distribution in the state of CT.

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Covidien HysteroLux Fluid Management System Control Unit, REF: 72205000