Recall Z-1316-2023 ยท FKX System, Peritoneal, Automatic Delivery
Baxter Healthcare Corporation
Automated Peritoneal Dialysis System. Used for automatic control of dialysis solution exchanges.
| Date | Apr 1, 2023 (initiated Feb 22, 2023) |
| Status | Open, Classified |
| Reason | The electrical safety testing was not properly performed on the impacted devices and additional testing is required |
| Root cause | Process design |
| Action | Baxter notified consignees via phone call on 02/22/2023. The notification outlined the issue and that Baxter was retrieving the units and then replacing them within 24 hours. |
| Quantity | 16 units |
| Distribution | US distribution to AL, AR, AZ, FL, IL, ND, NY, OH, TX, WA. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K201867 | Homechoice Claria APD System, Sharesource Connectivity Platform for Use with the Homechoice Claria APD System Baxter Healthcare Corporation, Nov 19, 2020 |