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
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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
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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 |
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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.
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510(K) Database | 510(K)s with Product Code = ODX
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