FDA Medical Device Recalls (openFDA)
Isopure Corp: Isopure Sodium Bicarbonate Mixing and Distribution System (IsoMix PRO) with a Finish Thompson Centrifugal Pump Model #110192-3
- Recall number
- Z-0822-2020
- Recalling firm
- Isopure Corp
- Product
- Isopure Sodium Bicarbonate Mixing and Distribution System (IsoMix PRO) with a Finish Thompson Centrifugal Pump Model #110192-3
- Status
- Terminated
- Initiated
- 2019-04-19
- Posted
- 2020-01-19
- Terminated
- 2020-05-29
- Reason
- 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.
- Root cause
- Nonconforming Material/Component
- Action
- 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.
- Quantity
- 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.
- Lot, serial or model codes
- IsoMix Pro UDI: (01)00852456007085; ISOMIX Serial Number IMP-838703 with Pump SN 180210D18
- 510(k) numbers
- ["K112427"]
- PMA numbers
- not on file
- Product code
- FIN
- Firm FEI
- 3013942511
- Firm city
- Louisville
- Firm state
- KY
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28