FDA-Device2021-06-23Class II
Dialysate Concentrate for Hemodialysis-Liquid/Powd - Product Usage: used in conjunction with bicarbonate in a compatible artificial kidney (hemodialysis) machine.
Medivators, Inc.
Hazard
The lot may have experienced an anomaly during the manufacturing process, that could lead to an out of specification concentrate formulation.
Sold states
US Nationwide distribution in the states of IA, IL, MN, ND, NY, OH, SD,WI.
Affected count
1,381 CASES
Manufactured in
14605 28th Ave N, Plymouth, MN, United States
Products
Dialysate Concentrate for Hemodialysis-Liquid/Powd - Product Usage: used in conjunction with bicarbonate in a compatible artificial kidney (hemodialysis) machine.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1859-2021Don't want to check this manually?
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