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U.S. Department of Health and Human Services

Class 2 Device Recall Dialysate Concentrate for HemodialysisLiquid/Powd

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  Class 2 Device Recall Dialysate Concentrate for HemodialysisLiquid/Powd see related information
Date Initiated by Firm April 20, 2021
Create Date June 15, 2021
Recall Status1 Completed
Recall Number Z-1859-2021
Recall Event ID 87894
510(K)Number K843963  
Product Classification System, dialysate delivery, central multiple patient - Product Code FKQ
Product Dialysate Concentrate for Hemodialysis-Liquid/Powd - Product Usage: used in conjunction with bicarbonate in a compatible artificial kidney (hemodialysis) machine.
Code Information Lot 489224
Recalling Firm/
Manufacturer		 Medivators, Inc.
14605 28th Ave N
Plymouth MN 55447-4822
For Additional Information Contact Medivators Customer Care
763-553-3300
Manufacturer Reason
for Recall		 The lot may have experienced an anomaly during the manufacturing process, that could lead to an out of specification concentrate formulation.
FDA Determined
Cause 2		 Process control
Action On 4/20/21 the firm initiated notification to its consignee via phone call, followed by a letter sent on 4/27/21 with the following instructions: 1. Quarantine and discontinue use of product from lot 489224, including dialysate produced with this lot of concentrate. 2. Contact Medivators Customer Service at 1-800-444-4729 or custserv@medivators.com to receive a return material authorization to return any unused product and receive replacement product. 3. Please return the enclosed Acknowledgement form via email to Happy-Sarah Kim at happy-sarah.kim@cantel.com 4. If this product was further distributed, notify your customer of the recall.
Quantity in Commerce 1,381 CASES
Distribution US Nationwide distribution in the states of IA, IL, MN, ND, NY, OH, SD,WI.
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.
510(K) Database 510(K)s with Product Code = FKQ and Original Applicant = RENAL SYSTEMS, INC.
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