Medical device recalls Moderate risk

Baxter Healthcare Corporation recalls power cord for: (a) AMIA Automated PD Cycler, Product Code: 5C9320; (b) Kaguya PD System, Product Code: T5C8500 (Japane…

Recall date
July 12, 2018
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-2597-2018
FDA classification
Class II
Brand / firm
Baxter Healthcare Corporation
Sold / distributed
US and Japan

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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

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