FDAMay 30, 2019device
Babi.Plus Bubble PAP Valve with 12.5 cm H2O Pressure Relief Manifold, REF 1002, Rx Only, UDI: 24710810093559
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
24710810093559190220190610
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
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