Recall Z-1828-2020 ยท KDI Dialyzer, High Permeability With Or Without Sealed Dialysate System
Baxter Healthcare Corporation
Prismaflex System, Prismaflex Control Unit
| Date | Feb 6, 2020 |
| Status | Terminated |
| Reason | Baxter is communicating safety information from the Prismaflex Operator's Manual regarding the proper use of connectors with the Prismaflex system. |
| Root cause | Under Investigation by firm |
| Action | Baxter is asking customers to: 1. Operators may continue to safely use the Prismaflex control unit according to the warnings and cautions in the Prismaflex Operators Manual. 2. Complete the enclosed Baxter Customer Reply Form and return it to Baxter by either fax or email. |
| Quantity | 4946 units |
| Distribution | Distribution in US, Puerto Rico |
| FDA record | Open on fda.gov |