Date Initiated by Firm |
April 03, 2019 |
Create Date |
June 01, 2019 |
Recall Status1 |
Terminated 3 on August 30, 2019 |
Recall Number |
Z-1699-2019 |
Recall Event ID |
82729 |
510(K)Number |
K173972
|
Product Classification |
Dialyzer, high permeability with or without sealed dialysate system - Product Code KDI
|
Product |
2008T BlueStar Machine Software v.2.72-Hemodialysis machine Model Number: 191126 - Product Usage: The 2008T hemodialysis machine is indicated for acute and chronic dialysis therapy in a healthcare facility. |
Code Information |
Software v.2.72 |
Recalling Firm/ Manufacturer |
Fresenius Medical Care Renal Therapies Group, LLC 920 Winter St Waltham MA 02451-1521
|
For Additional Information Contact |
Fresenius Medical Care Technical Service 800-227-2572
|
Manufacturer Reason for Recall |
Power Logic Board Fail Message on the 2008T BlueStar Machine with software version 2.72.
|
FDA Determined Cause 2 |
Nonconforming Material/Component |
Action |
Fresenius issued An IMPORTANT MEDICAL DEVICE CORRECTION notification explains the problem, health risk and that a Fresenius Service Technician (FST) will be contacting them to schedule the correction.
Questions, please contact Fresenius Technical Services at 800-227-2572. |
Quantity in Commerce |
257 units |
Distribution |
US Nationwide distribution. |
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
|