|
Class 2 Device Recall Fresenius Home Dialysis System |
|
Date Initiated by Firm |
December 21, 2016 |
Create Date |
January 13, 2017 |
Recall Status1 |
Terminated 3 on March 17, 2023 |
Recall Number |
Z-1028-2017 |
Recall Event ID |
76037 |
510(K)Number |
K150708
|
Product Classification |
Dialyzer, high permeability with or without sealed dialysate system - Product Code KDI
|
Product |
Fresenius 2008K2 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 |
60,151 units (US) 1773 (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
|
|
|
|