Isopure Sodium Bicarbonate Mixing and Distribution System (IsoMix PRO) with a Finish Thompson Centrifugal Pump Model #11
FDA device recall Z-0822-2020 · posted 2020-01-19 · Terminated
Recall details
- Recalling firm
- Isopure Corp
- 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.
- Action taken
- 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.
- Root cause
- Nonconforming Material/Component
- Status
- Terminated
- Product code
- FIN
- Quantity affected
- 1
- Distribution
- The products were distributed to the following US states: AL, FL, GA, MA, MD, MN, NC, NM, NY, OH, OK, TX, and VA.
- Date initiated
- 2019-04-19
- Date posted
- 2020-01-19
- Date terminated
- 2020-05-29
- Location
- Louisville, KY
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| BICARB MIXING AND DISTRIBUTION SYSTEM (K112427) | Isopure, Corp. | 2012-01-26 |