FDA (Devices) recall action 88622
The FDA (Devices) publishes a recall like this one as 4 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 4 pages.
Labeling does not include guidance for proper water-quality maintenance and device inspection for heater cooler devices.
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.
CardioQuip is recalling its Modular Cooler-Heater device because labeling omits proper guidance for water-quality maintenance and device inspection, affecting users' ability to maintain the device correctly.
CardioQuip is recalling 1,646 units of its Modular Cooler-Heater 1000(m) due to inadequate labeling. The device documentation lacks guidance on proper water-quality maintenance and inspection procedures required for safe operation.
FDA recalls 1,380 CardioQuip Modular Cooler-Heater 1000(i) devices worldwide due to labeling missing guidance on water-quality maintenance and device inspection procedures.
CardioQuip is recalling 1,478 Modular Cooler-Heater devices because the labeling does not include proper water-quality maintenance and device inspection guidance.