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U.S. Department of Health and Human Services

Class 2 Device Recall Fresenius Home Dialysis System

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  Class 2 Device Recall Fresenius Home Dialysis System see related information
Date Initiated by Firm December 21, 2016
Create Date January 13, 2017
Recall Status1 Terminated 3 on March 17, 2023
Recall Number Z-1029-2017
Recall Event ID 76037
510(K)Number K150708  
Product Classification Dialyzer, high permeability with or without sealed dialysate system - Product Code KDI
Product Fresenius 2008K@home Series : Hemodialysis System
Code Information All serial numbers
Recalling Firm/
Manufacturer		 Fresenius Medical Care Renal Therapies Group, LLC
920 Winter St
Waltham MA 02451-1521
For Additional Information Contact SAME
781-699-9000
Manufacturer Reason
for Recall		 When the UF Rate, Goal or Time is adjusted using the up and down arrow keys, and the change is cancelled by using the esc key, the cancelled UF Rate is actually being executed rather than rate displayed on the machine
FDA Determined
Cause 2		 Device Design
Action Fresenius issued Customer Notification via Certified Mail on 12/21/2016. Users provided with problem and recommendation, when adjusting the UF Rate, UF Goal, or Tx Time, is to use the numeric data entry keys instead of the up or down arrow keys. Change the values by using data entry keys, then save by pressing CONFIRM. Fresenius will make arrangements to install software on the hemodialysis machine. Confirmation of the noticed by the consignee will be required via a Reply Form.
Quantity in Commerce 1400 units (US) 556 units (OUS)
Distribution Nationwide Foreign: Canada, Mexico, Jamaica, Germany, Guam
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 = KDI and Original Applicant = FRESENIUS MEDICAL CARE RENAL THERAPIES GROUP, LLC
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