Isopure Corp Isopure Sodium Bicarbonate Mixing and Distribution System (IsoMix PRO) with a Finish Thompson Centrifugal Pump Model #110192-3 Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Isopure Sodium Bicarbonate Mixing and Distribution System (IsoMix PRO) with a Finish Thompson Centrifugal Pump Model #110192-3
Brand
Isopure Corp
Lot Codes / Batch Numbers
IsoMix Pro UDI: (01)00852456007085, ISOMIX Serial Number IMP-838703 with Pump SN 180210D18
Products Sold
IsoMix Pro UDI: (01)00852456007085; ISOMIX Serial Number IMP-838703 with Pump SN 180210D18
Isopure Corp is recalling Isopure Sodium Bicarbonate Mixing and Distribution System (IsoMix PRO) with a Finish Thompson Centri due to There is a potential for an uneven plastic encapsulation of the magnet ring during the molding process and partial axial displacement. This issue coul. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
AL, FL, GA, MD, MA, MN, NM, NY, NC, OH, OK, TX, VA
Page updated: Jan 10, 2026