Z-2597-2018Class II

power cord for: (a) AMIA Automated PD Cycler

Name: Z-2597-2018 power cord for: (a) AMIA Automated PD Cycler
Creator: Baxter Healthcare Corporation
Published: 2018-07-12
License: https://open.fda.gov/license/

Baxter Healthcare Corporation / initiated 2018-07-12 / Terminated

FDA source

Baxter Healthcare Corporation began a recall of power cord for: (a) AMIA Automated PD Cycler, Product Code: 5C9320; (b) Kaguya PD System, Product Code: T5C8500 (Japanese distribution only) on 2018-07-12. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-2597-2018
Classification: Class II
Status: Terminated
Initiated: 2018-07-12
Posted: 2018-08-02
Terminated: 2021-03-31
Recalling firm: Baxter Healthcare Corporation
Product: power cord for: (a) AMIA Automated PD Cycler, Product Code: 5C9320; (b) Kaguya PD System, Product Code: T5C8500 (Japanese distribution only)
Product code: FKX System, Peritoneal, Automatic Delivery
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.
FDA root cause: Under Investigation by 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.
Quantity in commerce: 5445 units
Distribution: US and Japan
Product codes and lots: All Serial Numbers

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2597-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2597-2018	Class II	Terminated	Voluntary: Firm initiated	2018-08-08	2018-08-02

Product code FKX

K151525Class IIAmia Automated PD System with SharesourceDeka Research and Development / cleared 2015-10-09

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)