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U.S. Department of Health and Human Services

Class 3 Device Recall Fresenius

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 Class 3 Device Recall Freseniussee related information
Date Initiated by FirmApril 03, 2019
Create DateJune 01, 2019
Recall Status1 Terminated 3 on August 30, 2019
Recall NumberZ-1699-2019
Recall Event ID 82729
510(K)NumberK173972 
Product Classification Dialyzer, high permeability with or without sealed dialysate system - Product Code KDI
Product2008T 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 
FEI Number 3001451489
Recalling Firm/
Manufacturer		 Fresenius Medical Care Renal Therapies Group, LLC
920 Winter St
Waltham MA 02451-1521
For Additional Information ContactFresenius 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
ActionFresenius 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 Commerce257 units
DistributionUS Nationwide distribution.
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 = KDI
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