Recall Z-3269-2011 ยท ODX Autonomous Extracorporeal Blood Leak Detector/Alarm
Fresenius Medical Care Holdings, Inc.
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
| Date | Sep 20, 2011 (initiated Aug 11, 2011) |
| Status | Terminated |
| Reason | Blood lines coiling tabs #1 and #5 on the arterial line are not in the correct positions |
| Root cause | 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 | 118 cases |
| Distribution | Nationwide Distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K070049 | FRESENIUS 2008K @HOME WITH WIRELESS WETNESS DETECTOR Fresenius Medical Care North America, Feb 3, 2011 |