FDA (Devices) recall action 61742
The FDA (Devices) publishes a recall like this one as 11 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 11 pages.
During production of one lot of the Sarns High-Flow Aortic Arch Cannula, Terumo Cardiovascular Systems (Terumo CVS) found a foreign substance on the outer surface of some cannulae connectors. Terumo CVS' preliminary investigation found that the substance can be dislodged from the cannula surface, the substance was likely deposited during the molding process, but the exact composition of the parti
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.
Terumo CVS is recalling Sarns High-Flow Aortic Arch Cannula kits because a foreign substance was found on the outer surface of some connectors.
Terumo CVS is recalling Sarns High-Flow Aortic Arch Cannulae because a foreign substance was found on the outer surface of some connectors that can be dislodged.
Terumo CVS is recalling Sarns Flexible Arterial Cannulas because a foreign substance was found on the connectors that could dislodge during use.
Terumo CVS is recalling Sarns High-Flow Aortic Arch Cannulas because a foreign substance found on connectors can be dislodged during use.
Terumo CVS is recalling Sarns High-Flow Aortic Arch Cannulae because a foreign substance was found on the outer surface of some connectors that could be dislodged.
Terumo CVS is recalling Sarns Flexible Arterial Cannulas because a foreign substance was found on the connectors that can be dislodged.
Terumo CVS is recalling Sarns Flexible Arterial Cannulas because a foreign substance found on the connector surface can be dislodged during use.
Terumo CVS is recalling Sarns Flexible Arterial Cannulas because a foreign substance found on the connectors can be dislodged during use.
Terumo CVS is recalling Sarns High-Flow Aortic Arch Cannula kits because a foreign substance was found on the outer surface of some connectors.
Terumo is recalling Sarns High-Flow Aortic Arch Cannulae because a foreign substance was found on the outer surface of some connectors.
Terumo CVS is recalling Sarns High-Flow Aortic Arch Cannulae because a foreign substance was found on the outer surface of some connectors.