CLASS II Device recall · Reported 29 Jan 2020 · FDA Enforcement Report
Sodium Bicarbonate Mixing and Distribution System recalled by Isopure
Isopure is recalling Isopure Sodium Bicarbonate Mixing and Distribution System (IsoMix PRO) with a Finish, distributed in 13 states. The recall was initiated on 19 Apr 2019 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0822-2020
- FDA event ID
- 83990
- Recalling firm
- Isopure, Louisville, KY
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 19 Apr 2019
- FDA classified
- 18 Jan 2020
- Reported
- 29 Jan 2020
- Type
- Voluntary: Firm initiated
- Customers notified by
- Telephone
- Reason category
- Foreign Material
- Device type
- Other Medical Devices
Timeline
| 19 Apr 2019 | Recall initiated by company | |
| 18 Jan 2020 | Classified by FDA | +274 days |
| 29 Jan 2020 | Published in enforcement report | +11 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Foreign material recalls cover pieces of metal, plastic, glass, wood or other objects that got into the product during processing and could cause injury if eaten.
Product as listed by the FDA
Isopure Sodium Bicarbonate Mixing and Distribution System (IsoMix PRO) with a Finish Thompson Centrifugal Pump Model #110192-3
Where it was distributed
The products were distributed to the following US states: AL, FL, GA, MA, MD, MN, NC, NM, NY, OH, OK, TX, and VA.
AlabamaFloridaGeorgiaMassachusettsMarylandMinnesotaNorth CarolinaNew MexicoNew YorkOhioOklahomaTexasVirginia
Questions about this recall
Is Sodium Bicarbonate Mixing and Distribution System (IsoMix PRO) with a Finish Thompson recalled?
Yes. Isopure recalled Sodium Bicarbonate Mixing and Distribution System (IsoMix PRO) with a Finish Thompson on 19 Apr 2019. The recall is Class II and its status is Terminated. Recall number Z-0822-2020.
Why was it 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.
Which lots are affected?
IsoMix Pro UDI: (01)00852456007085; ISOMIX Serial Number IMP-838703 with Pump SN 180210D18
Where was it sold?
The products were distributed to the following US states: AL, FL, GA, MA, MD, MN, NC, NM, NY, OH, OK, TX, and VA.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Isopure
All 5| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Acidified Concentrate Distribution recalled by Isopure | Isopure | Other | Nationwide |
| Device | CLASS II | Sodium Bicarbonate Mixing and Distribution System (IsoMix PRO) recalled | Isopure | Other | 19 states |
| Device | CLASS II | Finish Thompson Centrifugal Pump recalled by Isopure | Isopure | Foreign Material | 13 states |
| Device | CLASS II | Acidified Concentrate Distribution and Storage System recalled | Isopure | Foreign Material | 13 states |
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