Recall Z-2066-2020 ยท KDI Dialyzer, High Permeability With Or Without Sealed Dialysate System
Baxter Healthcare Corporation
Prismaflex Control Unit
| Date | Apr 7, 2020 |
| Status | Terminated |
| Reason | Prismaflex product code 114870 does not have FDA regulatory clearance and was inadvertently distributed. |
| Root cause | Under Investigation by firm |
| Action | Baxter notified customers on about 04/07/2020 via "URGENT MEDICAL DEVICE RECALL" letter. The letter instructed customers that the affected units can still be used until the replacement is performed, a local Baxter representative will contact each facility to schedule the replacement of affected devices, complete and return the Baxter Customer Reply Form by scanning and e-mailing it to perezd2@baxter.com, and if the affected devices have been further distributed, to please notify those customers by forwarding a copy of the recall notification. For general questions, contact Baxter Customer |
| Quantity | 5 devices US territories |
| Distribution | Distribution only to Puerto Rico and Guam |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K131516 | PRISMAFLEX SYSTEM 7.10 Gambro Renal Products, Inc., Jan 3, 2014 |