Recall Z-0629-2014 ยท KDI Dialyzer, High Permeability With Or Without Sealed Dialysate System
Fresenius Medical Care Holdings, Inc.
Fresenius 2008 Series Hemodialysis Machines: Models: 2008H, 2008K, 2008K2, 2008k@Home, 2008T The 2008H Hemodialysis machine is indicated for acute and chronic dialysis therapy. Hemodialysis is indicated for patients with acute or chronic renal failure, when conservative therapy is judged to be inadequate. The dialysate delivery machine is used for hemodialysis in hospital, dialysis centers, and a
| Date | Jan 6, 2014 (initiated Nov 12, 2013) |
| Status | Terminated |
| Reason | 2008 Series Hemodialysis Machines complaints of saline bags inappropriately filling during recirculation and setup |
| Root cause | Under Investigation by firm |
| Action | Fresenius Medical issued a Product Notification letter dated November 12, 2013, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers who encounter a saline bag that is inappropriately filling, should discontinue the setup and remove the machine from service until the drain line and drain-associated hydraulic components can be checed by a qualified service technician. Customers were also instructed to ensure that the hemodialysis machine is installed and operated in compliance with the Machine Specification section o |
| Quantity | 111,504 units US and 3,638 Canada and Mexico- |
| Distribution | Worldwide Distribution - USA (nationwide) and Internationally Mexico and Canada. |
| 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 |
| K093902 | MODIFICATION TO:FRESENIUS 2008T HEMODIALYSIS MACHINE, MODEL 190573 Fresenius Medical Care North America, May 27, 2010 |
| K921456 | FRESENIUS 3008/FDS-08 DIALYSATE DELIVERY SYSTEM Fresenius USA, Inc., Apr 20, 1994 |
| K994267 | FRESENIUS 2008K Fresenius Medical Care, Mar 16, 2000 |