CLASS II Device recall · Reported 14 Jan 2015 · FDA Enforcement Report

Baxter Amia Automated PD systems are used recalled by Baxter Healthcare

Baxter Healthcare is recalling Baxter Amia Automated PD systems are used in the treatment of adult renal failure, distributed nationwide in the US. The recall was initiated on 24 Apr 2014 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesProduct Code: 5C9310

Quantity recalled55 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-0932-2015
FDA event ID: 69586
Recalling firm: Baxter Healthcare, Deerfield, IL
Classification: Class II
Status: Terminated
Recall initiated: 24 Apr 2014
FDA classified: 7 Jan 2015
Reported: 14 Jan 2015
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Device Malfunction
Device type: Other Medical Devices

Timeline

24 Apr 2014	Recall initiated by company
7 Jan 2015	Classified by FDA	+258 days
14 Jan 2015	Published in enforcement report	+7 days

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

Reason for recall

System error 01779 is produced when the battery cannot be charged due to specific voltage differences between the battery and the charger.

Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.

Product as listed by the FDA

Baxter Amia Automated PD systems are used in the treatment of adult renal failure patients to perform automated peritoneal dialysis.

Where it was distributed

Nationwide Distribution including GA, MA, NC, NY, PA, and WA.

Nationwide Georgia Massachusetts North Carolina New York Pennsylvania Washington

Questions about this recall

Is Baxter Amia Automated PD systems are used in the treatment of adult renal failure recalled?

Yes. Baxter Healthcare recalled Baxter Amia Automated PD systems are used in the treatment of adult renal failure on 24 Apr 2014. The recall is Class II and its status is Terminated. Recall number Z-0932-2015.

Why was it recalled?

System error 01779 is produced when the battery cannot be charged due to specific voltage differences between the battery and the charger.

Which lots are affected?

Product Code: 5C9310

Where was it sold?

Nationwide Distribution including GA, MA, NC, NY, PA, and WA.

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 21 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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