FDA-Device2018-08-08Class II

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

Baxter Healthcare Corporation
Hazard

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.

Sold states
US and Japan
Affected count
5445 units
Manufactured in
1 Baxter Pkwy, N/A, Deerfield, IL, United States
Products
power cord for: (a) AMIA Automated PD Cycler, Product Code: 5C9320; (b) Kaguya PD System, Product Code: T5C8500 (Japanese distribution only)

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2597-2018

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