Recall Z-3133-2017 ยท FKX System, Peritoneal, Automatic Delivery
Baxter Healthcare Corp
Baxter Amia Automated Peritoneal Dialysis Set with Cassette, REF 5C5479
| Date | Sep 1, 2017 |
| Status | Terminated |
| Reason | The firm received increased customer complaints for Missing Red Line, Patient Slow Flow, Solution Slow Flow, and Inadequate Drain alerts on certain lots of the AMIA Automated Peritoneal Dialysis Set with Cassette. |
| Root cause | Equipment maintenance |
| Action | The firm initiated the recall by letter on 09/05/2017. The patients and clinics were directed to locate and remove all affected product and to contact Baxter Healthcare Center for Service to arrange for return and credit. The Baxter Healthcare Center for Service can be reached at 888-229-0001 between the hours of 7:00 am and 6:00 pm Central Time, Monday through Friday. |
| Quantity | 164,700 units |
| Distribution | nationwide, Canada |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K151525 | Amia Automated PD System with Sharesource Deka Research and Development, Oct 9, 2015 |