FDA (Devices) recall action 80076
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.
This lot of arterial cannula may have been supplied with 3/8-width de-airing plugs that could break during the process of removal from the arterial cannula.
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 is recalling Aortic Arterial Cannulas because de-airing plugs may break during removal. The defect could compromise the device's integrity during cardiopulmonary bypass.
Maquet Cardiopulmonary Ag is recalling specific lots of Aortic Arterial Cannulas because the de-airing plugs may break during removal.
Maquet Cardiopulmonary Ag is recalling specific lots of Aortic Arterial Cannulas because the de-airing plugs may break during removal.