Recall Z-1565-2016 ยท FKX System, Peritoneal, Automatic Delivery
Baxter Healthcare Corp.
Automated peritoneal dialysis (APD) cycler
| Date | Feb 16, 2016 |
| Status | Terminated |
| Reason | Baxter Healthcare Corporation is sending this communication to inform you of incomplete instructions in the AMIA Automated Peritoneal Dialysis (PO) System Clinician Guide for calculating the total recommended solution therapy volume. Specifically, the instructions do not specify the need for an extra 200 mL of PD solution in order to prime the patient line and for air purge operations. The tot |
| Root cause | Under Investigation by firm |
| Action | An Urgent Device Correction communication was sent to the one affected customer via U.S.P.S., first class mail on 02/11/2016. A Clinician Guide Addendum was created to instruct clinicians of the extra 200 mL of PD solution required to prime the patient line and for air purge operations. This Addendum was provided as an attachment to the Urgent Device Correction communication letter. |
| Quantity | 10 units |
| Distribution | US Consignee: NY ***Foreign Consignee: Ecuador |
| 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 |