FDA (Devices) recall action 71784
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.
Infant Heel warmers may break during activation resulting in spillage of the contents on patients or healthcare worker causing potential skin/eye irritations
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.
The FDA is recalling 68,800 units of Infant Heel Warmers because they may break during activation, causing spillage of contents that could irritate skin or eyes.
The FDA is recalling 164,749 units of Covidien Infant Heel Warmers because they may break during activation, causing spillage and potential skin or eye irritation.