FDAJuly 26, 2022device
Acidified 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...
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
Acidified Concentrate Distribution System potential electrical safety hazard may result in electric shock, arching
What to do
FDA enforcement status: Terminated
Brands named
isopure
UPCs
00852456007092
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
- 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
- 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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