FDA (Devices) recall action 83990
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.
There is a potential for an uneven plastic encapsulation of the magnet ring during the molding process and partial axial displacement. This issue could cause uneven wear during use, cause exposure of the magnet to solution, and thereby result in corrosion and the presence of iron.
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.
Isopure Corp is recalling eight Finish Thompson Centrifugal Pumps due to a manufacturing defect that could expose magnets to solution, causing corrosion and iron contamination.
Isopure Corp is recalling 15 Acidified Concentrate Distribution and Storage Systems due to a potential magnet encapsulation defect that could cause corrosion and iron exposure.
Isopure Corp is recalling one IsoMix PRO system due to a potential magnet encapsulation defect that could cause corrosion and iron exposure.