Isopure Sodium Bicarbonate Mixing and Distribution System… recallZ-0822-2020 · Isopure Corp · initiated Apr 19, 2019

Terminated

Is my device affected?

Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
If yours is listed, follow the instructions from Isopure Corp or your healthcare provider. The company's action is summarized under what the company is doing.
Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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.

FDA root cause category: Nonconforming Material/Component

What the company is doing

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.

Recall details

Recall number: Z-0822-2020
Status: Terminated
Initiated by the company: Apr 19, 2019
Posted by the FDA: Jan 19, 2020
Recalling firm: Isopure Corp
Quantity: 1
Product code: FIN
FDA submissions: K112427
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 description

Isopure Sodium Bicarbonate Mixing and Distribution System (IsoMix PRO) with a Finish Thompson Centrifugal Pump Model #110192-3

Code information (models, lots, serial numbers)

IsoMix Pro UDI: (01)00852456007085; ISOMIX Serial Number IMP-838703 with Pump SN 180210D18

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

Sodium Bicarbonate Mixing and Distribution System IsoMix PRO
Isopure, Corp. · Tank, Holding, Dialysis
2 recalls0 reports

Other products in the same recall event

The FDA groups related products into one recall event (event 83990).

Z-0821-2020 · Terminated
Acidified Concentrate Distribution and Storage System (ACDS System) with a Finish Thompson Centrifugal Pump Model #110192-3

Sources and updates

Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.

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