Isopure Sodium Bicarbonate Mixing and Distribution System — Class II medical device recall Z-0822-2020
Terminated recall by Isopure Corp, reported 2020-01-29, distributed in AL, FL, GA, MA, MD, MN, NC, NM…. There is a potential for an uneven plastic encapsulation of the magnet ring during the molding process and par
| Recall number | Z-0822-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Isopure Corp, Louisville, KY, United States |
| Recall initiated | 2019-04-19 |
| Classified | 2020-01-18 |
| Reported by FDA | 2020-01-29 |
| Terminated | 2020-05-29 |
| Distributed | AL, FL, GA, MA, MD, MN, NC, NM, NY, OH, OK, TX, VA |
| Quantity | 1 |
| UPC / GTIN / UDI-DI | 00852456007085 |
| Serial numbers | IMP-838703 |
| Model numbers | 110192-3 |
Product
Isopure Sodium Bicarbonate Mixing and Distribution System (IsoMix PRO) with a Finish Thompson Centrifugal Pump Model #110192-3
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0822-2020. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.