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U.S. Department of Health and Human Services

Class 2 Device Recall Acidified Concentrate Distribution and Storage System

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 Class 2 Device Recall Acidified Concentrate Distribution and Storage Systemsee related information
Date Initiated by FirmApril 19, 2019
Date PostedJanuary 19, 2020
Recall Status1 Terminated 3 on May 29, 2020
Recall NumberZ-0821-2020
Recall Event ID 83990
510(K)NumberK120005 
Product Classification Dialysate concentrate for hemodialysis (liquid or powder) - Product Code KPO
ProductAcidified Concentrate Distribution and Storage System (ACDS System) with a Finish Thompson Centrifugal Pump Model #110192-3
Code Information 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
Recalling Firm/
Manufacturer		 Isopure Corp
11851 Plantside Dr
Louisville KY 40299-6328
For Additional Information ContactKim 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
ActionThe 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 Commerce15
DistributionThe 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 CycleTPLC 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) Database510(K)s with Product Code = KPO
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