FDA (Devices) recall action 83376
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.
The manual does not provide instruction stating that exceeding 40 Celsius for extended periods can cause tissue damage.
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.
Cincinnati Sub-Zero Products LLC is recalling Norm-O-Temp model 111Z devices because the manual lacks instructions warning that exceeding 40 Celsius for extended periods can cause tissue damage.
Cincinnati Sub-Zero Products LLC is recalling Norm-O-Temp model 111W units because the manual lacks instructions warning that exceeding 40 Celsius for extended periods can cause tissue damage.