Recall Z-0550-2024 ยท FKX System, Peritoneal, Automatic Delivery
Baxter Healthcare Corporation
Baxter Amia Automated Peritoneal Dialysis (APD) Cycler Set, REF 5C5479
| Date | Dec 14, 2023 (initiated Nov 15, 2023) |
| Status | Open, Classified |
| Reason | There is to an increase in complaints related to failure alarms for Wet Cassette Integrity Test occurring on the Amia devices. |
| Root cause | Process control |
| Action | Baxter issued an Urgent Medical Device Recall notice to its consignees on 11/15/2023 by US Mail. The notice explained the issue, potential risk, and requested the following: Isolate and cease all use of the affected units pending return. |
| Quantity | 339,936 devices |
| Distribution | Worldwide distribution - US Nationwide and the country of 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 |