FDA (Devices) recall action 63407
The FDA (Devices) publishes a recall like this one as 7 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 7 pages.
The presence of plastic flash was identified at the tip of certain lots of Sarns Soft-Flow Aortic Cannula. The plastic flash has the potential to detach and contribute to an adverse patient effect. While this potential failure has not been reported from the field as an observed defect, it was determined that the product does not meet specifications and this condition could result in an unacceptabl
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 is recalling Sarns Soft-Flow Aortic Cannulas because plastic flash at the tip may detach and cause adverse patient effects.
Terumo is recalling Sarns Aortic Cannulas because plastic flash at the tip may detach and harm patients during surgery.
Terumo is recalling Sarns Aortic Cannulas because plastic flash at the tip could detach and harm patients during surgery.
Terumo is recalling Sarns Soft-Flow Aortic Cannulas because plastic flash at the tip may detach and cause adverse patient effects.
Terumo is recalling Sarns Aortic Cannulas because plastic flash at the tip may detach and harm patients during surgery.
Terumo is recalling Sarns Soft-Flow Aortic Cannulas because plastic flash at the tip may detach and cause adverse patient effects.
Terumo is recalling Sarns Soft-Flow Aortic Cannulas because plastic flash at the tip may detach and cause adverse patient effects.