FDA recall Z-1859-2021

Medivators, Inc. · Class II · device

Product

Dialysate Concentrate for Hemodialysis-Liquid/Powd - Product Usage: used in conjunction with bicarbonate in a compatible artificial kidney (hemodialysis) machine.

Reason for recall

The lot may have experienced an anomaly during the manufacturing process, that could lead to an out of specification concentrate formulation.

Distribution

US Nationwide distribution in the states of IA, IL, MN, ND, NY, OH, SD,WI.

Key facts

Status
Terminated
Initiation date
2021-04-20
Report date
2021-06-23
Termination date
2024-07-11
Voluntary/Mandated
Voluntary: Firm initiated
Location
Plymouth, MN, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1859-2021