FDA (Devices) recall action 89644
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 damage to the power cord may cause the power conductors to be exposed, thereby creating a risk of shock from the power mains.
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 Healthcare is recalling the Compella Therapy Air Supply Unit due to potential power cord damage that could expose electrical conductors and create a shock risk. The recall affects 6,022 units distributed worldwide.
Baxter Healthcare is recalling the Compella Bariatric Bed System due to potential power cord damage that could expose electrical conductors, creating a shock hazard. Approximately 5186 units worldwide are affected.