Isopure Sodium Bicarbonate Mixing System Recalled for Magnet Encapsulation Defect
Isopure Corp is recalling one IsoMix PRO system due to a potential magnet encapsulation defect that could cause corrosion and iron exposure.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a risk-of-harm product (potential iron contamination) where injury has not yet been reported, fitting the 'High' severity criteria.
Plain-English summary
Isopure Corp is recalling one unit of the Isopure Sodium Bicarbonate Mixing and Distribution System (IsoMix PRO) with a Finish Thompson Centrifugal Pump Model #110192-3. The recall is due to a potential manufacturing defect involving uneven plastic encapsulation of the magnet ring during the molding process.
This defect could cause partial axial displacement and uneven wear during use. These issues may expose the magnet to the solution, resulting in corrosion and the presence of iron. The product was distributed to facilities in Alabama, Florida, Georgia, Massachusetts, Maryland, Minnesota, North Carolina, New Mexico, New York, Ohio, Oklahoma, Texas, and Virginia.
The source text does not specify instructions for consumers or end-users on how to handle the recalled unit. The recall number is Z-0822-2020.
The recalled product
- Product
- Isopure Sodium Bicarbonate Mixing and Distribution System (IsoMix PRO) with a Finish Thompson Centrifugal Pump Model #110192-3
- Manufacturer
- Isopure Corp
- Hazard
- Affected units
- 1
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- IsoMix Pro UDI: (01)00852456007085
- ISOMIX Serial Number IMP-838703 with Pump SN 180210D18
Distribution
Part of a larger recall action
This product is one of 3 recalled by Isopure Corp under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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