Recall Z-2082-2013 ยท KDI Dialyzer, High Permeability With Or Without Sealed Dialysate System
Fresenius Medical Care Holdings, Inc. dba Renal Solutions
2008 MeDS Pump, Venofer(R) Pump Product Usage: The 2008 MeDs pump is an optional accessory for use with the Fresenius 2008 Series Hemodialysis Machines and is intended to administer Venofer to treat iron deficiency anemia in patients with chronic kidney disease undergoing hemodialysis, where Venofer, in conjunction with hemodialysis, is prescribed by a physician.
| Date | Aug 26, 2013 (initiated Apr 1, 2013) |
| Status | Terminated |
| Reason | Product is being recalled because the combination of the current 50 mg vial, the 2008 MeDS pump, and the 2008 MeDS pump tubing Set for CombiSet Bloodlines can lead to a situation where Venofer(R) delivery does not meet dosage accuracy requirements. This may lead to a slight over or under delivery of Venofer(R) that does not pose an acceptable risk to the patient. Please note that this recall |
| Root cause | Device Design |
| Action | Renal Solutions sent an Urgent Notification letter dated April 1, 2013 via certified mail to all affected customers. The letter identified the affected product, problem and actions to be taken. Customers were instructed to cease further use of the device. The letter informed customers that a Fresenius Medical Care Technical Service/Customer Service representative will contact customers to arrange for removal of the device. For questions contact Fresenius Medical Care Customer Service at 800-227-2572. |
| Quantity | 132 |
| Distribution | USA Nationwide Distribution in the states of CA, MA, and NY. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K121497 | VENOFER PUMP Renal Solutions, Inc., Aug 17, 2012 |