Recall Z-1325-2016 ยท KDI Dialyzer, High Permeability With Or Without Sealed Dialysate System
Fresenius Medical Care Renal Therapies Group, LLC
Fresenius 2008 Series Hemodialysis Delivery Systems: 2008T, 2008K2, 2008K and 2008K@home: Models: Fresenius 2008K and 2008K2 Dialysate Delivery System Fresenius 2008K@home Hemodialysis Machine with bibag System 2008T Hemodialysis Machine The Fresenius 2008 Series Machines are indicated for acute and chronic dialysis therapy
| Date | Apr 5, 2016 (initiated Mar 10, 2016) |
| Status | Terminated |
| Reason | Added Warning Statement: Fresenius 2008 Series Hemodialysis Machines False Blood Leak Alarm When Dialyzing Patients Treated with Hydroxocobalamin (or any form of Vitamin B-12) |
| Root cause | Device Design |
| Action | Fresenius Medical Care issued an Urgent Medical Device Alert dated March 10, 2016, to all affected consignees. Consignees were instructed to place notification and Warning Addendum with their 2008 Series Hemodialysis Machine Operators Manual. A reply form was included as part of the customer communication with instructions to fill out and return via fax or scanned/emailed copy. Further information or support concerning this issue, customers were instructed to contact Fresenius Technical Services at 800-227-2572. |
| Quantity | 8384 units (8369 US) (15 OUS) |
| Distribution | Nationwide Distribution |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K080964 | FRESENIUS MODEL 2008T HEMODIALYSIS MACHINE Fresenius Medical Care North America, Jan 14, 2009 |
| K113427 | FRESENIUS 2008T HEMODIALYSIS MACHINE Fresenius Medical Care North America, Dec 21, 2011 |
| K120017 | FRESENIUS 2008 HEMODIAYSIS MACHINE WITH BIBAG SYSTEM Fresenius Medical Care North America, Feb 2, 2012 |
| K120505 | FRESENIUS 2008T HEMODIALYSIS MACHINE Fresenius Medical Care North America, Design Cente, Mar 6, 2012 |
| K121341 | FRESENIUS 2008T HEMODIALYSIS MACHINE WITH BIBAG SYSTEM Fresenius Medical Care North America, Dec 6, 2012 |