FDA (Devices) recall action 94713
The FDA (Devices) publishes a recall like this one as 2 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 2 pages.
Potential of the handset plug to disconnect from the nebulizer port on the blue ventilator adapter. The handset plug is required to ensure proper operation and ventilator gas flow.
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.
Baxter's Volara System SPU circuit kits may have a faulty handset plug that disconnects from the nebulizer adapter, preventing proper ventilator gas flow.
Baxter Healthcare is recalling 350 units of the Volara System Blue Ventilator Adapter Module because the handset plug may disconnect from the nebulizer port, disrupting ventilator gas flow. Affected units were distributed nationwide and internationally.