FDA (Devices) recall action 83318
The FDA (Devices) publishes a recall like this one as 3 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 3 pages.
Reports of pressure relief manifold venting gas below the standard pressure.
The agency’s own wording, quoted from the enforcement report.
The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.
Galemed is recalling Babi.Plus 12.5 cm H2O Pressure Relief Manifolds because they may vent gas below standard pressure. The recall covers 14,964 units distributed in North Carolina and Nevada.
Galemed Corporation is recalling Babi.Plus 12.5 cm H2O Pressure Relief Manifolds because they may vent gas below standard pressure.
Galemed Corporation is recalling Babi.Plus Bubble PAP Valves because the pressure relief manifold may vent gas below standard pressure.