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U.S. Department of Health and Human Services

Class 2 Device Recall Fresenius Medical CombiSet True Flow"

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  Class 2 Device Recall Fresenius Medical CombiSet True Flow" see related information
Date Initiated by Firm August 11, 2011
Date Posted September 20, 2011
Recall Status1 Terminated 3 on August 24, 2016
Recall Number Z-3269-2011
Recall Event ID 59664
510(K)Number K070049  
Product Classification Autonomous Extracorporeal Blood Leak Detector/Alarm - Product Code ODX
Product CombiSet¿ True Flow" 2008K@home Bloodlines
Fresenius Medical Care.

Used for transferring blood during the hemodialysis treatment from the patient to the dialyzer (artificial kidney), removing extra water and waste products and then returning the filtered blood back to the patient

Code Information Product Code: 03-2962-3  Lot Numbers: 11ER01800 11ER01801 11ER01802 11ER01804  Exp. Date 05-2014 
Recalling Firm/
Manufacturer		 Fresenius Medical Care Holdings, Inc.
920 Winter St
Waltham MA 02451-1521
For Additional Information Contact SAME
800-662-1237
Manufacturer Reason
for Recall		 Blood lines coiling tabs #1 and #5 on the arterial line are not in the correct positions
FDA Determined
Cause 2		 Device Design
Action Fresenius Medical Care sent out an "Urgent" recall notice dated August 11, 2011 to all affected customers . The letter included description of the product name, problem and asked them to examine their stock immediately and quarantine bloodlines from the recalled lots. Customers were asked to return the product to Fresenius. For information on this recall call the Fresenius Customer Service Team at 1-800-323-5188.
Quantity in Commerce 118 cases
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 = ODX and Original Applicant = FRESENIUS MEDICAL CARE NORTH AMERICA
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