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U.S. Department of Health and Human Services

Class 2 Device Recall 2008T Hemodialysis Machine

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  Class 2 Device Recall 2008T Hemodialysis Machine see related information
Date Initiated by Firm February 20, 2015
Date Posted April 29, 2015
Recall Status1 Terminated 3 on May 18, 2021
Recall Number Z-1550-2015
Recall Event ID 70574
510(K)Number K121341  K120505  K080964  K120017  K113427  
Product Classification Dialyzer, high permeability with or without sealed dialysate system - Product Code KDI
Product 2008 Series Hemodialysis Machines: 2008T with the following product code and description: 190395 2008K at Home System - 1st Gen. -¿ Canada;
190828 2008K at Home System - 2nd Gen - U.S.; 190904 2008K at Home System w/ Bibag; 190828 2008KatHOME HEMODIALYSIS SYSTEM;
190395 2008KatHOME MACHINE, SHORT CAB, OLC/DP, HP

The Fresenius 2008K is indicated for acute and chronic dialysis therapy.
Code Information Serial Numbers: 0T0S100031- 101358, 1T0S101359- 127938, 2T0S109489- 118130, 3T0S118131- 126163, 4T0S126164- 135408, 9T0S100002, 9T0S100004, 9T0S100007- 100010, 9T0S100012, 9T0S100014- 100016 
Recalling Firm/
Manufacturer		 Fresenius Medical Care Holdings, Inc.
920 Winter St
Waltham MA 02451-1521
For Additional Information Contact
800-227-2572
Manufacturer Reason
for Recall		 The Acetate value for GranuFlo on the Select Concentrate screen should be 8mEq/l but it is displayed as 4mEq/l. The correct value is shown on the dialysate screen.
FDA Determined
Cause 2		 Software design
Action The firm, Fresenius Medical Care, sent an "URGENT - MEDICAL DEVICE CORRECTION" letter dated February 19, 2015 to its Consignees via certified mail on February 26, 2015. The letter describes the product, problem and actions to be taken. The consignees were instructed to sign and return the attached "Reply Form" via fax to: 781-699-9769 Attn: Quality Department or Scan and E-mail to: NOTIFYRA@fmc-na.com to confirm that they received and understand the customer notification. The firm will be providing a software update and stated that in the near future, your local clinic will be contacting you about installing the software update. If you have any questions pertaining to this Customer Notification, please contact your local clinic, 800-227-2572 or the Corrections and Removals Manager at 800-662-1237.
Quantity in Commerce 133,751 in total (US: 130,337 and OUS: Canada 1,201 and Mexico 2,213)
Distribution Worldwide Distribution: US (Nationwide) and countries of: Canada and Mexico.
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 NORTH AMERICA
510(K)s with Product Code = KDI and Original Applicant = FRESENIUS MEDICAL CARE NORTH AMERICA, DESIGN CENTE
510(K)s with Product Code = KDI and Original Applicant = FRESENIUS MEDICAL CARE, NORTH AMERICA
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