WOM World Of Medicine AG recalls Aquilex Fluid Control System-Intended to provide fluid distension of the uterus during diagnostic and operative hystero…

Recall date

July 17, 2023

Source

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

Recall number

Z-2629-2023

FDA classification

Class II

Brand / firm

WOM World Of Medicine AG

Sold / distributed

Nationwide Foreign: Canada, Australia, New Zealand, Belgium, France, Germany, Ireland, Netherlands, Spain, Sweden, Norway, Switzerland, UK, Kuwait, Qatar, Turkey, UAE

Why it was recalled

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

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

What was recalled

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