FDAApril 19, 2019device
Isopure Sodium Bicarbonate Mixing and Distribution System (IsoMix PRO) with a Finish Thompson Centrifugal Pump Model #110192-3
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
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.
What to do
FDA enforcement status: Terminated
Brands named
isopure
UPCs
00852456007085
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
- FDAAcidified Concentrate Distribution and Storage-The Isopure ACDS (Acidified Concentrate Distribution and Storage) with remote fill is intended to be used in Hemodialysis facilities for the storage and distribution of acid concentrate to be used in the treatment of Hemodialysis patients Model: ACDS...2022-07-26
- FDAIsopure Sodium Bicarbonate Mixing and Distribution System (IsoMix PRO)2022-04-28
- FDAAcidified Concentrate Distribution and Storage System (ACDS System) with a Finish Thompson Centrifugal Pump Model #110192-32019-04-19
- FDAFinish Thompson Centrifugal Pump Model #110192-3 (sold as spare part)2019-04-19
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