Recall Z-1551-2015 ยท KDI Dialyzer, High Permeability With Or Without Sealed Dialysate System
Fresenius Medical Care Holdings, Inc.
2008 Series Hemodialysis Machines: 2008K with the following product code and description: 190305 2008K (w/ OLC); 190371 2008K System Std (w/OLC and Diasafe Plus); 190300 2008K System Std (w/OLC and Diasafe); 190336 2008K System w/ Fifth Module Holder; 190517 2008K System w/ OLC and Diasafe Plus - Spanish; 190302 2008K System w/ OLC and Short Cab; 190306 2008K System w/ Short Cabinet; 190373 2008K
| 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
| K994267 | FRESENIUS 2008K Fresenius Medical Care, Mar 16, 2000 |