CLASS II Device recall · Reported 4 May 2016 · FDA Enforcement Report

Automated peritoneal dialysis (APD) cycler recalled by Baxter Healthcare

Baxter Healthcare is recalling Automated peritoneal dialysis (APD) cycler, distributed in New York. The recall was initiated on 16 Feb 2016 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesN/A

Quantity recalled10 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-1565-2016
FDA event ID: 73435
Recalling firm: Baxter Healthcare, Deerfield, IL
Classification: Class II
Status: Terminated
Recall initiated: 16 Feb 2016
FDA classified: 25 Apr 2016
Reported: 4 May 2016
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Other Medical Devices

Timeline

16 Feb 2016	Recall initiated by company
25 Apr 2016	Classified by FDA	+69 days
4 May 2016	Published in enforcement report	+9 days

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

Reason for recall

Baxter Healthcare Corporation is sending this communication to inform you of incomplete instructions in the AMIA Automated Peritoneal Dialysis (PO) System Clinician Guide for calculating the total recommended solution therapy volume. Specifically, the instructions do not specify the need for an extra 200 mL of PD solution in order to prime the patient line and for air purge operations. The tot

Product as listed by the FDA

Automated peritoneal dialysis (APD) cycler

Where it was distributed

US Consignee: NY ***Foreign Consignee: Ecuador

New York

Questions about this recall

Why was it recalled?

Which lots are affected?

N/A

Where was it sold?

US Consignee: NY ***Foreign Consignee: Ecuador

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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