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Terminated

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

FDA Recall Z-2597-2018 · Posted None

Recalling FirmBaxter Healthcare Corporation
Recall StatusTerminated
Product CodeFKX
Date Initiated2018-07-12
Date Terminated2021-03-31
Product Quantity5445 units

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.

Firm Action

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.

Root Cause

Under Investigation by firm

Distribution Pattern

US and Japan

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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