Data Foundry

Medical device recalls 2020

Acidified Concentrate Distribution and Storage System — Class II medical device recall Z-0821-2020

Terminated recall by Isopure Corp, reported 2020-01-29, distributed in AL, FL, GA, MA, MD, MN, NC, NM…. There is a potential for an uneven plastic encapsulation of the magnet ring during the molding process and par

Recall numberZ-0821-2020
Product typeMedical device
ClassificationClass II
StatusTerminated
Voluntary or mandatedVoluntary
Recalling firmIsopure Corp, Louisville, KY, United States
Recall initiated2019-04-19
Classified2020-01-18
Reported by FDA2020-01-29
Terminated2020-05-29
DistributedAL, FL, GA, MA, MD, MN, NC, NM, NY, OH, OK, TX, VA
Quantity15
UPC / GTIN / UDI-DI00852456007092
Serial numbers178752C18, AC-834638, AC-837654, AC-837664, AC-837864, AC-837874, AC-838020, AC-838030, AC-838050, AC-838143, AC-838173, AC-838260, AC-838740, AC-838743, AC-838746, AC-838749
Model numbers110192-3

Product

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

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.

Machine access

This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0821-2020. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.

Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.