FDA (Devices) recall action 67996
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.
The firm received several complaints for internal blood leaks involving various lot numbers produced in late 2013.
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.
Gambro Renal Products is recalling Polyflux Revaclear capillary dialyzers due to reports of internal blood leaks.
Gambro Renal Products is recalling Polyflux Revaclear Max dialyzers due to reports of internal blood leaks. The recall covers 2,461,824 units distributed worldwide.