Z-1859-2021Class II

Dialysate Concentrate for Hemodialysis-Liquid/Powd -

Name: Z-1859-2021 Dialysate Concentrate for Hemodialysis-Liquid/Powd -
Creator: Medivators, Inc.
Published: 2021-04-20
License: https://open.fda.gov/license/

Medivators Inc / initiated 2021-04-20 / Terminated / root cause: manufacturing process

FDA source

Medivators, Inc. began a recall of Dialysate Concentrate for Hemodialysis-Liquid/Powd - Product Usage: used in conjunction with bicarbonate in a compatible artificial kidney (hemodialysis)... on 2021-04-20. FDA classified it as Class II and gives the reason as "The lot may have experienced an anomaly during the manufacturing process, that could lead to an out of specification concentrate formulation". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1859-2021
Classification: Class II
Status: Terminated
Initiated: 2021-04-20
Posted: 2021-06-15
Terminated: 2024-07-11
Recalling firm: Medivators Inc
Product: Dialysate Concentrate for Hemodialysis-Liquid/Powd - Product Usage: used in conjunction with bicarbonate in a compatible artificial kidney (hemodialysis) machine.
Product code: FKQ System, Dialysate Delivery, Central Multiple Patient
Reason for recall: The lot may have experienced an anomaly during the manufacturing process, that could lead to an out of specification concentrate formulation.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: On 4/20/21 the firm initiated notification to its consignee via phone call, followed by a letter sent on 4/27/21 with the following instructions: 1. Quarantine and discontinue use of product from lot 489224, including dialysate produced with this lot of concentrate. 2. Contact Medivators Customer Service at 1-800-444-4729 or [email protected] to receive a return material authorization to return any unused product and receive replacement product. 3. Please return the enclosed Acknowledgement form via email to Happy-Sarah Kim at [email protected] 4. If this product was further distributed, notify your customer of the recall.
Quantity in commerce: 1,381 CASES
Distribution: US Nationwide distribution in the states of IA, IL, MN, ND, NY, OH, SD,WI.
Product codes and lots: Lot 489224

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1859-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1859-2021	Class II	Terminated	Voluntary: Firm initiated	2021-06-23	2021-06-15

Product code FKQ

K843963Class IIDialysate Concentrate for Hemodialysis-Liquid/powdRenal Systems, Inc. / cleared 1985-01-07

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)