FDA-Device2022-09-21Class II
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 MD704262
Isopure Corp
Hazard
Acidified Concentrate Distribution System potential electrical safety hazard may result in electric shock, arching
Sold states
US Nationwide distribution.
Affected count
595 units
Manufactured in
11851 Plantside Dr, Louisville, KY, United States
Products
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 MD704262
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1739-2022Don't want to check this manually?
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