Z-1031-2015Class II

HomeChoice/HomeChoice Pro Automated Personal Cycler, for Automated Peritoneal Dialysis. Product codes 5C8310...

Name: Z-1031-2015 HomeChoice/HomeChoice Pro Automated Personal Cycler, for Automated Peritoneal Dialysis. Product codes 5C8310...
Creator: Baxter Healthcare Corp.
Published: 2014-10-21
License: https://open.fda.gov/license/

Baxter Healthcare Corporation / initiated 2014-10-21 / Terminated / root cause: manufacturing process

FDA source

Baxter Healthcare Corp. began a recall of HomeChoice/HomeChoice Pro Automated Personal Cycler, for Automated Peritoneal Dialysis. Product codes 5C8310, 5C8310R, R5C8320, and 5C4474 on 2014-10-21. FDA classified it as Class II and gives the reason as "The keypad buttons on HomeChoice devices may be activated without the operator pressing them". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1031-2015
Classification: Class II
Status: Terminated
Initiated: 2014-10-21
Posted: 2015-01-29
Terminated: 2015-09-01
Recalling firm: Baxter Healthcare Corporation
Product: HomeChoice/HomeChoice Pro Automated Personal Cycler, for Automated Peritoneal Dialysis. Product codes 5C8310, 5C8310R, R5C8320, and 5C4474.
Product code: FKX System, Peritoneal, Automatic Delivery
Reason for recall: The keypad buttons on HomeChoice devices may be activated without the operator pressing them.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: An Urgent Device Correction notification was sent to consignees on October 31, 2014. Within the notification, Baxter Healthcare asked customers to do the following: 1) Contact Baxter Technical Services to arrange for the exchange (swap) of any affected HomeChoice PRO Automated PD System devices. 2) Complete the attached customer reply form and return it to Baxter by either fax or scanned e-mail. For general questions regarding this communication, contact The Center for One Baxter at 900-422-9837, Monday through Friday between the hours of 8:00 AM and 5:00 PM Central Time.
Quantity in commerce: 200
Distribution: 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
Product codes and lots: all codes distributed between 4/15/2014 and 6/11/2014

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1031-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1031-2015	Class II	Terminated	Voluntary: Firm initiated	2015-02-04	2015-01-29

Product code FKX

K102936Class IIHomechoice/homechoice Pro Automated Personal Cycler Peritoneal Dialysis System Model 5C4471, 5C8310, 5C4471r and 5C8310rBaxter Healthcare Corp / cleared 2011-03-30

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)