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U.S. Department of Health and Human Services

Class 1 Device Recall Dialog Hemodialysis machine: Dialog 120 V DFAdimeaWANBSL

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  Class 1 Device Recall Dialog Hemodialysis machine: Dialog 120 V DFAdimeaWANBSL see related information
Date Initiated by Firm April 01, 2016
Date Posted May 03, 2016
Recall Status1 Terminated 3 on July 11, 2017
Recall Number Z-1533-2016
Recall Event ID 73744
510(K)Number K963440  K083460  
Product Classification Dialyzer, high permeability with or without sealed dialysate system - Product Code KDI
Product Dialog+ Hemodialysis machines: Dialog + 120 V DF+Adimea+WAN-BSL
Product Code # 710200S
Serial # >200805 and <204001
The Dialog+ can be used for implementing and monitoring hemodialysis treatments for patients with acute or chronic kidney failure. The system can be used in hospital, health center and outpatient dialysis center settings when prescribed by a Physician. The following types of renal replacement therapy can be carried out with the system: Hemodialysis (HD) with or without phases of pure ultrafiltration, High flux hemodialysis and low flux hemodialysis.
Code Information Product Code 710200S Serial Number Range; 200805-204001
Recalling Firm/
Manufacturer		 B Braun Medical Inc
824 12th Ave
Bethlehem PA 18018-3524
For Additional Information Contact Antonio Ribeiro
610-997-4717
Manufacturer Reason
for Recall		 Potential leakage of conductivity sensors of the Dialog Dialysis machines.
FDA Determined
Cause 2		 Process control
Action B. Braun mailed an Urgent Medical Device Correction notice to affected customers informing them of the Dialog+Hemodialysis System due to the potential for Bicarbonate and End conductivity cells (3456102A and 3456103A respectively) to exhibit cracks. Notice provided customers with actions for Qualified Service Technicians, Clinical Personnel Administering Dialysis treatment and adverse event reporting. All Dialog+Hemodialysis machines will be inspected at the customer's site by the customer Biomed, who has been trained and qualified by B. Braun Avitum. The inspection of each machine will be performed in accordance to a Field Service Information (FSI). Customers with questions were instructed to contact the Technical Support Team at 800-621-0445 or the Customers Service Team at 800-848-2066. For questions regarding this recall call 610-997-4717.
Quantity in Commerce 318 units
Distribution Nationwide Distribution to ND, OH, CA, VA, FL, LA, SC, IL, UT, AZ, KY, IA, WI, OK, TN, SD, AL, NJ, TX, NM, NY, KS, WA, MO, CO, PA, CT, DE, GA, MD, VA, Puerto Rico, and St. Thomas USVI
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 = B. BRAUN AVITUM AG
510(K)s with Product Code = KDI and Original Applicant = B. BRAUN MEDICAL AG
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