Recall Z-0278-2020 ยท KDI Dialyzer, High Permeability With Or Without Sealed Dialysate System
Baxter Healthcare Corporation
Prismaflex Control Unit, software versions below 7.21
| Date | Oct 4, 2019 |
| Status | Open, Classified |
| Reason | Communication error alarms may result in interruption of therapy, delay in therapy, or blood loss due to non-restitution of blood in the extracorporeal circuit. |
| Root cause | Software design |
| Action | Baxter Healthcare notified customers on about 10/04/2019, via "URGENT MEDICAL DEVICE CORRECTION" letter. Customers were informed that Prismaflex Control Units with software versions 7.20 and below have the potential to produce communication errors. Instructions included that operators may continue to use the control units until the upgrade is performed, but if a communication error alarm does occur, follow the instructions presented on the graphical user interface and/or in the operators manual. It must be reinforced that it is important to manually return the extracorporeal blood to the |
| Quantity | 988 units |
| Distribution | Nationwide distribution to AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI, WV, WY. International distribution to Australia, Bangladesh, Brunei, China, Ho |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K072093 | PRISMAFLEX SYSTEM, VERSION 3.20 Gambro, Feb 1, 2008 |