CLASS II Device recall · Reported 4 Feb 2015 · FDA Enforcement Report

HomeChoice/HomeChoice Pro Automated Personal Cycler recalled

Baxter Healthcare is recalling HomeChoice/HomeChoice Pro Automated Personal Cycler, for Automated Peritoneal Dialysis, distributed in 36 states. The recall was initiated on 21 Oct 2014 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesall codes distributed between 4/15/2014 and 6/11/2014

Quantity recalled200

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-1031-2015
FDA event ID: 70232
Recalling firm: Baxter Healthcare, Deerfield, IL
Classification: Class II
Status: Terminated
Recall initiated: 21 Oct 2014
FDA classified: 29 Jan 2015
Reported: 4 Feb 2015
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Other Medical Devices

Timeline

21 Oct 2014	Recall initiated by company
29 Jan 2015	Classified by FDA	+100 days
4 Feb 2015	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

The keypad buttons on HomeChoice devices may be activated without the operator pressing them.

Product as listed by the FDA

HomeChoice/HomeChoice Pro Automated Personal Cycler, for Automated Peritoneal Dialysis. Product codes 5C8310, 5C8310R, R5C8320, and 5C4474.

Where it was distributed

AL, AR, AZ, CA, CO, CT, FL, GA, IA, ID, IL, IN, KS, LA, MA, MD, MI, MO, NC, NE, NJ, NM, NV, NY, OH, OK, PA, SC, TN, TX, UT, VA, VT, WA, WI and District of Columbia

Alabama Arkansas Arizona California Colorado Connecticut District of Columbia Florida Georgia Iowa Idaho Illinois Indiana Kansas Louisiana Massachusetts Maryland Michigan Missouri North Carolina

Questions about this recall

Why was it recalled?

The keypad buttons on HomeChoice devices may be activated without the operator pressing them.

Which lots are affected?

all codes distributed between 4/15/2014 and 6/11/2014

Where was it sold?

AL, AR, AZ, CA, CO, CT, FL, GA, IA, ID, IL, IN, KS, LA, MA, MD, MI, MO, NC, NE, NJ, NM, NV, NY, OH, OK, PA, SC, TN, TX, UT, VA, VT, WA, WI and District of Columbia

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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