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Recall Observatory FDA recall evidence

Device product

Isopure Sodium Bicarbonate Mixing and Distribution System (IsoMix PRO) with a Finish Thompson Centrifugal Pump Model #110192-3

Z-0822-2020

April 19, 2019

Class II

Product summary

Firm
Isopure Corp
Event
Event 83990
Status
Terminated
Classification
Class II
Quantity
1
Official record key
device-enforcement:Z-0822-2020

Official wording

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.

Code information: IsoMix Pro UDI: (01)00852456007085; ISOMIX Serial Number IMP-838703 with Pump SN 180210D18

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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.