Recall Z-0215-2022 ยท KDI Dialyzer, High Permeability With Or Without Sealed Dialysate System
Baxter Healthcare Corporation
Hemodialysis Delivery System, Software Version 2.x.
| Date | Sep 29, 2021 |
| Status | Open, Classified |
| Reason | If the operator initiates therapy with a saved prescription profile and makes a change to the prescription after a disposable filter change using the Same Patient button, the system may suggest values from the original prescription profile, rather than the current prescription. |
| Root cause | Software design |
| Action | An Urgent Medical Device Correction communication was sent to affected customers via U.S.P.S., first class mail, on 09/29/2021. Baxter advises the following: 1. Operators may continue to safely use the PrisMax System with software version 2.x until the system is upgraded to version 3.x. To ensure patient safety, operators must follow the Operator s Manual and confirm all prescription fields are accurate prior to starting treatment, or when making prescription changes during therapy. The instructions can be found in the PrisMax Operating Instructions section of the Operator s Manual. Addition |
| Quantity | 4248 |
| Distribution | Distributed nationwide to AL, AR, AZ, CA, CO, CT, FL, GA, HI, ID, IL, IN, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NH, NJ, NM, NV, NY, OH, OR, PA, SC,SD, TN, TX, UT, VA, WA, WI and internationally to Mexico, Brazil, Canada, Australia, Singapore, Hong Kong, Vietnam, Austria, Belgium, Denmark, Finl |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K190910 | PrisMax System Version 2 Baxter Healthcare Corp, Jul 25, 2019 |