Recall Z-3195-2018 ยท KDI Dialyzer, High Permeability With Or Without Sealed Dialysate System
Fresenius Medical Care Renal Therapies Group, LLC
2008T HEMODIALYSIS SYSTEM W/BIBAG, Part Number 190766, Applicable only with 2008T BlueStar Premium Upgrade Kit, Part Number 191138 Product Usage: Indicated for acute and chronic dialysis therapy.
| Date | Jul 13, 2018 |
| Status | Terminated |
| Reason | In the hemodialysis machine during the cleaning/disinfection program, when there is a power failure or interruption, the dialysis program button should be greyed out when the machine is powered up and a mandatory rinse should be required. However, if a power failure or interruption occurs during the cleaning/disinfection program with the auto-start feature enabled, the machine enters the dialysis program even though the dialysis program button is disabled and the mandatory rinse has not been performed. As a result, disinfecting chemical may not be completely removed from the machine before sta |
| Root cause | Under Investigation by firm |
| Action | On 07/13/2018 phone calls were immediately conducted to the affected clinics. Contact was made to the Technical Service Directors explaining issue and to disable the Auto Start Function on their BlueStar SW v2.71 installed 2008T Hemodialysis Machines. |
| Quantity | 40 |
| Distribution | US Nationwide in the states of : CA, CT, MI, NC, and NY. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K173972 | 2008T BlueStar Hemodialysis Machine Fresenius Medical Care Renal Therapies Group, LLC, May 10, 2018 |