FDA (Devices) recall action 88210
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.
Instructions for use updated to include the following cautionary statement for the heel warmer, "Activate away from the user's face and away from the infant and others."
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 Regard Newborn Kit heel warmer is being recalled. Updated instructions now require that the device be activated away from the user's face and away from the infant and others.
ROi CPS LLC is recalling the Regard NEWBORN KIT heel warmer (976 units in Missouri) due to incomplete safety instructions. Updated instructions now warn users to activate the device away from the infant's face and others.
ROi CPS LLC is updating instructions for the Regard NEWBORN KIT infant heel warmer (688 units in Missouri) to include a warning: activate away from the face, infant, and others.