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FDAAugust 14, 2019device

Aquilex Fluid Control System component: Bag deflector, REF AQL-100CBS Product Usage: Distends uterus with fluid during diagnostic and operative hysteroscopies.

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

The hazard

The deficit displayed by the pump can differ from the real deficit, leading potentially to patient risk.

What to do

FDA enforcement status: Terminated

Brands named

wom worldwom

UPCs

04056702006556

Recall history

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

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