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U.S. Department of Health and Human Services

Class 2 Device Recall Isopure Sodium Bicarbonate Mixing and Distribution System

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  Class 2 Device Recall Isopure Sodium Bicarbonate Mixing and Distribution System see related information
Date Initiated by Firm April 19, 2019
Date Posted January 19, 2020
Recall Status1 Terminated 3 on May 29, 2020
Recall Number Z-0822-2020
Recall Event ID 83990
510(K)Number K112427  
Product Classification Tank, holding, dialysis - Product Code FIN
Product Isopure Sodium Bicarbonate Mixing and Distribution System (IsoMix PRO) with a Finish Thompson Centrifugal Pump Model #110192-3
Code Information IsoMix Pro UDI: (01)00852456007085; ISOMIX Serial Number IMP-838703 with Pump SN 180210D18
Recalling Firm/
Manufacturer		 Isopure Corp
11851 Plantside Dr
Louisville KY 40299-6328
For Additional Information Contact Kim Riseling
502-267-7873 Ext. 6640
Manufacturer 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.
FDA Determined
Cause 2		 Nonconforming Material/Component
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.
Quantity in Commerce 1
Distribution The products were distributed to the following US states: AL, FL, GA, MA, MD, MN, NC, NM, NY, OH, OK, TX, and VA.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = FIN and Original Applicant = ISOPURE CORP.
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