Z-0822-2020Class II

Isopure Sodium Bicarbonate Mixing and Distribution System (IsoMix PRO) with a Finish Thompson Centrifugal...

Name: Z-0822-2020 Isopure Sodium Bicarbonate Mixing and Distribution System (IsoMix PRO) with a Finish Thompson Centrifugal...
Creator: Isopure Corp
Published: 2019-04-19
License: https://open.fda.gov/license/

Isopure Corp / initiated 2019-04-19 / Terminated / root cause: manufacturing process

FDA source

Isopure Corp began a recall of Isopure Sodium Bicarbonate Mixing and Distribution System (IsoMix PRO) with a Finish Thompson Centrifugal Pump Model #110192-3 on 2019-04-19. FDA classified it as Class II and gives the reason as "There is a potential for an uneven plastic encapsulation of the magnet ring during the molding process and partial axial displacement. This issue could cause uneven wear during use, cause exposure of the magnet to...". 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-0822-2020
Classification: Class II
Status: Terminated
Initiated: 2019-04-19
Posted: 2020-01-19
Terminated: 2020-05-29
Recalling firm: Isopure Corp
Product: Isopure Sodium Bicarbonate Mixing and Distribution System (IsoMix PRO) with a Finish Thompson Centrifugal Pump Model #110192-3
Product code: FIN Tank, Holding, Dialysis
Reason for recall: There is a potential for an uneven plastic encapsulation of the magnet ring during the molding process and partial axial displacement. This issue could cause uneven wear during use, cause exposure of the magnet to solution, and thereby result in corrosion and the presence of iron.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: The only affected customer was contacted via telephone on 4/19/19. An URGENT PRODUCT FIELD CORRECTION NOTICE dated 5/22/19 was distributed to affected clinics.
Quantity in commerce: 1
Distribution: The products were distributed to the following US states: AL, FL, GA, MA, MD, MN, NC, NM, NY, OH, OK, TX, and VA.
Product codes and lots: IsoMix Pro UDI: (01)00852456007085; ISOMIX Serial Number IMP-838703 with Pump SN 180210D18

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0822-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0821-2020	Class II	Terminated	Voluntary: Firm initiated	2020-01-29	2020-01-18
Z-0822-2020	Class II	Terminated	Voluntary: Firm initiated	2020-01-29	2020-01-18
Z-0823-2020	Class II	Terminated	Voluntary: Firm initiated	2020-01-29	2020-01-18

Product code FIN

K112427Class IIBicarb Mixing and Distribution SystemIsopure, Corp. / cleared 2012-01-26

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)