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Recall Observatory FDA recall evidence

Device product

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

Z-1859-2021

April 20, 2021

Class II

Product summary

Firm
Medivators, Inc.
Event
Event 87894
Status
Terminated
Classification
Class II
Quantity
1,381 CASES
Official record key
device-enforcement:Z-1859-2021

Official wording

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

Code information: Lot 489224

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

Derived failure modes

  • Potency or specification failure

    reason.potency_specification_failure · v1.0.0

    out of specification