FDA recall Z-2597-2018

Baxter Healthcare Corporation · Class II · device

Product

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

Reason for recall

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.

Distribution

US and Japan

Key facts

Status
Terminated
Initiation date
2018-07-12
Report date
2018-08-08
Termination date
2021-03-31
Voluntary/Mandated
Voluntary: Firm initiated
Location
Deerfield, IL, United States

Primary source

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