Isopure Corp: 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.

Agency Publication Date: January 19, 2020

Affected Products

Product: Acidified Concentrate Distribution and Storage System (ACDS System) with a Finish Thompson Centrifugal Pump Model #110192-3

ACDS UDI: (01)00852456007092; ACDS Serial Number AC-837874 with Pump SN 178745C18; ACDS Serial Number AC-834638 with Pump SN 180212D18; ACDS Serial Number AC-837654 with Pump SN 178324B18; ACDS Serial Number AC-837864 with Pump SN 178743C18; ACDS Serial Number AC-837664 with Pump SN 178322B18; ACDS Serial Number AC-838050 with Pump Serial Number 178752C18; ACDS Serial Number AC-838030 with Pump SN 178746C18; ACDS Serial Number AC-838020 with Pump SN 178748C18; ACDS Serial Number AC-838173 with Pump SN 178744C18; ACDS Serial Number AC-838143 with Pump SN 178325B18; ACDS Serial Number AC-838260 with Pump SN 180211D18; ACDS Serial Number AC-838740 with Pump SN 180209D18; ACDS Serial Number AC-838743 with Pump SN 180207D18; ACDS Serial Number AC-838749 with Pump SN 180215D18; ACDS Serial Number AC-838746 with Pump SN 180206D18

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

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

Product: Finish Thompson Centrifugal Pump Model #110192-3 (sold as spare part)

Pump Serial Numbers: 178323B18, 178751C18, 178749C18, 180214D18, 180213D18, 180208D18, 178747C18, 178750C18

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 83990

Status: Resolved

Manufacturer: Isopure Corp

Manufactured In: United States

Units Affected: 3 products (15; 1; 8)

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AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

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