—#165664

Product

power cord for: (a) AMIA Automated PD Cycler, Product Code: 5C9320; (b) Kaguya PD System, Product Code: T5C8500 (Japanese distribution only)

FDA product code: FKX — System, Peritoneal, Automatic Delivery
Device class: Class 2
Medical specialty: Gastroenterology, Urology
510(k) numbers: K151525
Affected lot / code info: All Serial Numbers

Why it was recalled

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 (FDA determination)

Under Investigation by firm

Action the firm took

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.

Recalling firm

Firm: Baxter Healthcare Corporation
Address: 1 Baxter Pkwy, Deerfield, Illinois 60015-4625

Distribution

Distribution pattern: US and Japan

Timeline

Recall initiated: 2018-07-12
Terminated: 2021-03-31
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #165664. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.