Medivators, Inc.: Medical Device Recall in 2021 - (Recall #: Z-1859-2021)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2021.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: April 20, 2021

Date Posted: June 23, 2021

Recall Number: Z-1859-2021

Event ID: 87894

Reason for Recall:

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

Status: Terminated

Product Quantity: 1,381 CASES

Code Information:

Lot 489224

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated