FDA (Devices) recall action 68244
The FDA (Devices) publishes a recall like this one as 2 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 2 pages.
An evaluation of the APS1 Operator Manual found that existing instructions lack clarity and accuracy related to specific items.
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 1,713 Advanced Perfusion System 1 units because the operator manual lacks clarity and accuracy.
Terumo is recalling 1,713 Advanced Perfusion System 1 units because the operator manual lacks clarity and accuracy in specific instructions.