FDA (Devices) recall action 84541
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 for thermal damage near the power cord connector and Power Entry Module (PEM) due to improper connection of the power cord connector and PEM pins on the Cocoon Convective Warming System.
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.
Care Essentials is recalling 251 Cocoon Convective Warming Systems due to a potential for thermal damage near the power cord connector and Power Entry Module.
Care Essentials is recalling 689 Cocoon Convective Warming Systems due to a risk of thermal damage near the power cord connector and Power Entry Module.