Isopure Sodium Bicarbonate Mixing and Distribution System (IsoMix PRO) with a Finish Thompson Centrifugal Pump Model #110192-3
This recall has been terminated (originally issued January 19, 2020).
- Company
- Isopure Corp
- Recall Initiated
- April 19, 2019
- Posted
- January 19, 2020
- Terminated
- May 29, 2020
- Recall Number
- Z-0822-2020
- Quantity
- 1
- Firm Location
- Louisville, KY
- Official Source
- View on FDA website ↗
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
The products were distributed to the following US states: AL, FL, GA, MA, MD, MN, NC, NM, NY, OH, OK, TX, and VA.
Lot / Code Info
IsoMix Pro UDI: (01)00852456007085; ISOMIX Serial Number IMP-838703 with Pump SN 180210D18
Root Cause
Nonconforming Material/Component
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.