FDAClass IIJune 23, 2021

Dialysate Concentrate for Hemodialysis-Liquid/Powd recall

Dialysate Concentrate for Hemodialysis-Liquid/Powd - Product Usage: used in conjunction with bicarbonate in a compatible artificial kidney…

Why was Dialysate Concentrate for Hemodialysis-Liquid/Powd recalled?

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

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Lot 489224

Product
Dialysate Concentrate for Hemodialysis-Liquid/Powd - Product Usage: used in conjunction with bicarbonate in a compatible artificial kidney…
Recalling firm
Medivators, Inc.
Quantity
1,381 CASES
Distribution
US Nationwide distribution in the states of IA, IL, MN, ND, NY, OH, SD,WI.
Recall date
June 23, 2021
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls