Recall Z-2597-2018 ยท FKX System, Peritoneal, Automatic Delivery
Baxter Healthcare Corporation
power cord for: (a) AMIA Automated PD Cycler, Product Code: 5C9320; (b) Kaguya PD System, Product Code: T5C8500 (Japanese distribution only)
| Date | Jul 12, 2018 |
| Status | Terminated |
| Reason | There were instances where the power cord socket detached from the back of the AMIA cycler when the power cord was unplugged from the socket. |
| Root cause | Under Investigation by firm |
| Action | Method of Notification: A Safety Alert communication will be sent to affected customers via U.S.P.S., first class mail. Mitigating Instructions: Baxter is asking customers to: 1. Unplug the devices from the wall before unplugging the power cord from the back of the cycler. 2. Confirm the receipt of the letter by completing the enclosed customer reply form and returning it to Baxter by either mail, fax, or scanned email. |
| Quantity | 5445 units |
| Distribution | US and Japan |
| 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 |