FDAMay 30, 2019device

Babi.Plus 12.5 cm H2O Pressure Relief Manifold with Gas Supply Tube and Oxygen Sensor Port, REF 2691, Rx Only, UDI: 04710810100802

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

The hazard

Reports of pressure relief manifold venting gas below the standard pressure.

What to do

FDA enforcement status: Terminated

Brands named

galemed

UPCs

04710810100802

Recall history

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

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