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FDAFebruary 7, 2024device

smiths medical Pneupac paraPAC plus 300 ventilator kit without PEEP and CPAP, REF P300NUS

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

The hazard

When a paraPAC plus ventilator is switched to the operating mode of VENTILATE, the ventilator may intermittently provide continuous positive gas flow instead of the intended cycling like a human breath. This non-cycling and continuous positive gas flow when in the cycling mode, is a malfunction, not allowing the ventilator to properly function as designed.

What to do

FDA enforcement status: Ongoing

Brands named

smiths medical asdsmithssmiths medical

Recall history

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

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