CLASS II Device recall · Reported 8 Aug 2018 · FDA Enforcement Report

power cord for: (a) AMIA Automated PD Cycler, Product recalled

Baxter Healthcare is recalling power cord for: (a) AMIA Automated PD Cycler. The recall was initiated on 12 Jul 2018 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesAll Serial Numbers

Quantity recalled5445 units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-2597-2018
FDA event ID: 80522
Recalling firm: Baxter Healthcare, Deerfield, IL
Classification: Class II
Status: Terminated
Recall initiated: 12 Jul 2018
FDA classified: 2 Aug 2018
Reported: 8 Aug 2018
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Other Medical Devices

Timeline

12 Jul 2018	Recall initiated by company
2 Aug 2018	Classified by FDA	+21 days
8 Aug 2018	Published in enforcement report	+6 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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.

Product as listed by the FDA

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

Where it was distributed

US and Japan

Questions about this recall

Why was it recalled?

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.

Which lots are affected?

All Serial Numbers

Where was it sold?

US and Japan

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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