Recall Z-1015-2015 ยท KDI Dialyzer, High Permeability With Or Without Sealed Dialysate System
Fresenius Medical Care Holdings, Inc.
ASSY, POWER SUPPLY 130V 50HZ. This component is used with the following machines: 2008T Hemodialysis Machine, 2008K Hemodialysis Delivery Equipment, 2008 K2 Hemodialysis Delivery Equipment 2008K@home Hemodialysis Delivery System
| Date | Jan 27, 2015 (initiated Dec 16, 2014) |
| Status | Terminated |
| Reason | Unqualified power assemblies shipped to customers. |
| Root cause | Under Investigation by firm |
| Action | Consignees were notified of the recall via letter sent on 12/18/2014 via certified mail. The letter informs consignees of the recall and requests that they take the following steps: Please check your stock for any 50 Hz Power Supplies (P/N 190092) with the name Electro Assemblies, LLC which is visible on the Transformer contained inside the Power Supply and discontinue use. Place the product in a secure, segregated area. Please contact your Fresenius Technical Services at 1-800-227-2572 option 4 then option 1, and reference the Field Action Number above. They will issue you a Return Good Aut |
| Quantity | 10 |
| Distribution | Distributed in OK and FL. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K121341 | FRESENIUS 2008T HEMODIALYSIS MACHINE WITH BIBAG SYSTEM Fresenius Medical Care North America, Dec 6, 2012 |
| K121421 | FRESENIUS 2008K HOME HEMODIALYSIS MACHINE WITH WIRELESS WETNESS DETECTOR (WETALERT) Fresenius Medical Care North America, Design Cente, Jan 17, 2013 |
| K994267 | FRESENIUS 2008K Fresenius Medical Care, Mar 16, 2000 |