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U.S. Department of Health and Human Services

Class 2 Device Recall Fresenius 2008 Series Hemodialysis Delivery Systems

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  Class 2 Device Recall Fresenius 2008 Series Hemodialysis Delivery Systems see related information
Date Initiated by Firm March 10, 2016
Date Posted April 05, 2016
Recall Status1 Terminated 3 on March 09, 2017
Recall Number Z-1325-2016
Recall Event ID 73487
510(K)Number K121341  K120505  K080964  K120017  K113427  
Product Classification Dialyzer, high permeability with or without sealed dialysate system - Product Code KDI
Product Fresenius 2008 Series Hemodialysis Delivery Systems: 2008T, 2008K2, 2008K and 2008K@home:
Models:
Fresenius 2008K and 2008K2 Dialysate Delivery System
Fresenius 2008K@home Hemodialysis Machine with bibag System
2008T Hemodialysis Machine
The Fresenius 2008¿ Series Machines are indicated for acute and chronic dialysis therapy
Code Information Fresenius 2008 Series Hemodialysis Delivery Systems: 2008T, 2008K2, 2008K and 2008K@home: Models: Fresenius 2008K and 2008K2 Dialysate Delivery System Fresenius 2008K@home Hemodialysis Machine with bibag System 2008T Hemodialysis Machine
Recalling Firm/
Manufacturer		 Fresenius Medical Care Renal Therapies Group, LLC
920 Winter St
Waltham MA 02451-1521
For Additional Information Contact SAME
800-227-2572
Manufacturer Reason
for Recall		 Added Warning Statement: Fresenius 2008 Series Hemodialysis Machines False Blood Leak Alarm When Dialyzing Patients Treated with Hydroxocobalamin (or any form of Vitamin B-12)
FDA Determined
Cause 2		 Device Design
Action Fresenius Medical Care issued an Urgent Medical Device Alert dated March 10, 2016, to all affected consignees. Consignees were instructed to place notification and Warning Addendum with their 2008¿ Series Hemodialysis Machine Operators Manual. A reply form was included as part of the customer communication with instructions to fill out and return via fax or scanned/emailed copy. Further information or support concerning this issue, customers were instructed to contact Fresenius Technical Services at 800-227-2572.
Quantity in Commerce 8384 units (8369 US) (15 OUS)
Distribution 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 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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