Z-0822-2020 Class II Terminated
FDA device recall Z-0822-2020 was initiated by Isopure Corp on Apr 19, 2019 and is designated Class II. 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 recall status is terminated (terminated May 29, 2020). Affected quantity: 1.
Recall details
- Product Type
- Devices
- Report Date
- Jan 29, 2020
- Initiation Date
- Apr 19, 2019
- Termination Date
- May 29, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1
Product description
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.
Distribution pattern
The products were distributed to the following US states: AL, FL, GA, MA, MD, MN, NC, NM, NY, OH, OK, TX, and VA.
Code information
IsoMix Pro UDI: (01)00852456007085; ISOMIX Serial Number IMP-838703 with Pump SN 180210D18
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0822-2020
- openFDA file date
- Nov 10, 2026
- Loaded by RegDataLab
- Nov 11, 2026