FDAApril 28, 2022device
Isopure Sodium Bicarbonate Mixing and Distribution System (IsoMix PRO)
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
Isopure received a report of a hazardous incident involving a device which had experienced an electrical short that resulted in a thermal event, damaging some of the device components. The firm is alerting customers to electrical safety measures that can be taken to prevent such events from occurring.
What to do
FDA enforcement status: Ongoing
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
- FDAAcidified Concentrate Distribution and Storage System (ACDS System) with a Finish Thompson Centrifugal Pump Model #110192-32019-04-19
- FDAIsopure Sodium Bicarbonate Mixing and Distribution System (IsoMix PRO) 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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