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FDAJuly 17, 2023device

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

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

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

What to do

FDA enforcement status: Ongoing

Brands named

wom worldwom

UPCs

04056702006914

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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