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Terminated

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

FDA Recall Z-0822-2020 · Posted 2020-01-19

Recalling FirmIsopure Corp
Recall StatusTerminated
Product CodeFIN
Date Initiated2019-04-19
Date Terminated2020-05-29
Product Quantity1

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.

Firm 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.

Root Cause

Nonconforming Material/Component

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.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K112427BICARB MIXING AND DISTRIBUTION SYSTEMIsopure, Corp. · 2012-01-26

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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