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FDAJune 18, 2021device

Covidien HysteroLux Fluid Management System Control Unit, REF: 72205000

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

The hazard

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.

What to do

FDA enforcement status: Ongoing

Brands named

wom worldwom

Recall history

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

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