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Recall Observatory FDA recall evidence

Device product

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

Z-2597-2018

July 12, 2018

Class II

Product summary

Firm
Baxter Healthcare Corporation
Event
Event 80522
Status
Terminated
Classification
Class II
Quantity
5445 units
Official record key
device-enforcement:Z-2597-2018

Official wording

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.

Code information: All Serial Numbers

Distribution pattern: US and Japan

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.