Recall Z-1550-2015 ยท KDI Dialyzer, High Permeability With Or Without Sealed Dialysate System
Fresenius Medical Care Holdings, Inc.
2008 Series Hemodialysis Machines: 2008T with the following product code and description: 190395 2008K at Home System - 1st Gen. - Canada; 190828 2008K at Home System - 2nd Gen - U.S.; 190904 2008K at Home System w/ Bibag; 190828 2008KatHOME HEMODIALYSIS SYSTEM; 190395 2008KatHOME MACHINE, SHORT CAB, OLC/DP, HP The Fresenius 2008K is indicated for acute and chronic dialysis therapy.
| Date | Apr 29, 2015 (initiated Feb 20, 2015) |
| Status | Terminated |
| Reason | The Acetate value for GranuFlo on the Select Concentrate screen should be 8mEq/l but it is displayed as 4mEq/l. The correct value is shown on the dialysate screen. |
| Root cause | Software design |
| Action | The firm, Fresenius Medical Care, sent an "URGENT - MEDICAL DEVICE CORRECTION" letter dated February 19, 2015 to its Consignees via certified mail on February 26, 2015. The letter describes the product, problem and actions to be taken. The consignees were instructed to sign and return the attached "Reply Form" via fax to: 781-699-9769 Attn: Quality Department or Scan and E-mail to: NOTIFYRA@fmc-na.com to confirm that they received and understand the customer notification. The firm will be providing a software update and stated that in the near future, your local clinic will be contacting you |
| Quantity | 133,751 in total (US: 130,337 and OUS: Canada 1,201 and Mexico 2,213) |
| Distribution | Worldwide Distribution: US (Nationwide) and countries of: Canada and Mexico. |
| 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 |