FDA (Devices) recall action 73390
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.
Maquet Cardiopulmonary (MCP) is conducting a voluntary recall based on the potential risk of exposure to endotoxin for various products.
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.
Maquet Cardiovascular is voluntarily recalling HLS Set Advanced oxygenator tubing packs due to a potential risk of exposure to endotoxin.
Maquet Cardiovascular is voluntarily recalling QUADROX-i oxygenators and tubing packs due to a potential risk of endotoxin exposure.
Maquet Cardiovascular is voluntarily recalling Rotaflow Centrifugal Pump custom tubing packs due to a potential risk of endotoxin exposure.
Maquet Cardiovascular is voluntarily recalling 72,000 custom tubing packs for oxygenators due to a potential risk of endotoxin exposure.