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Z-0939-2015 Class II Terminated

Recalled by Baxter Healthcare Corp. — Deerfield, IL

FDA device recall Z-0939-2015 was initiated by Baxter Healthcare Corp. on Oct 6, 2014 and is designated Class II. Reason for recall: There are additional and updated warning and cautions that are not in the Patient At-Home Guide for HomeChoice Automated PD Systems and HomeChoice PRO Automated PD Systems. The recall status is terminated (terminated Mar 28, 2016). Affected quantity: 96,458 systems.

Recall Details

Product Type: Devices
Report Date: Jan 14, 2015
Initiation Date: Oct 6, 2014
Termination Date: Mar 28, 2016
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 96,458 systems

Product Description

HomeChoice Automated PD system and HomeChoice Pro Automated PD system Baxter's HomeChoice and HomeChoice Pro APD systems are designed to provide Automated Peritoneal Dialysis (APD) therapy for pediatric and adult renal patients. Their Fill volumes can range from 60 mL to 3000 mL. The HomeChoice and HomeChoice Pro APD systems are intended to be operated by: 1) Home patients whose physicians have prescribed this system. Patients, or their caregivers, must have received adequate training to use the system. 2) Clinicians who are using the system for patients under their care and under a prescription. Clinicians must have received adequate training to use the system. Since drain and volume requirements vary among patients, both the HomeChoice and HomeChoice Pro APD systems have a choice of modes, either Standard Fill Mode (Standard Mode) or Low Fill Mode. The dialysis center selects the Fill mode for the patient before therapy begins. The HomeChoice APD system and HomeChoice Pro APD system are the same in operation, except for the Pro Card and modem features that are only available with the HomeChoice Pro APD system. The Pro Card feature stores prescription and therapy data. The data can be transferred between your cycler and your clinician. The two systems use the same disposable sets and solutions. They perform the same therapies the same way.

Reason for Recall

There are additional and updated warning and cautions that are not in the Patient At-Home Guide for HomeChoice Automated PD Systems and HomeChoice PRO Automated PD Systems.

Distribution Pattern

Worldwide Distribution: US (nationwide) Including states of: AK, AL, AR, AZ, CA, CO, CT, DE, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY and District of Columbia; and countries of: Algeria, Argentina, Aruba, Australia, Austria, Bahamas, Bahrain, Barbados, Belarus, Belgium, Bosnia, Brazil, Bulgaria, Cayman Islands, Chile, Colombia, Croatia, Cuba, Czech Republic, Denmark, Ecuador, Egypt, El Salvador, Estonia, Finland, France, Georgia, Germany, Greece, Guatemala, Honduras, Hong Kong, Hungary, India, Iran, Iraq, Ireland, Israel, Italy, Jamaica, Japan, Jordan, Kazakhstan, Kuwait, Lebanon, Macedonia, Malaysia, Malta, Mexico, Morocco, Netherlands, New Zealand, Nicaragua, Norway, Oman, Panama, Poland, Portugal, Quatar, Romania, Russia, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Tunisia, Turkey, United Arab Emirates, United Kingdom, and Venezuela.

Code Information

Product Codes: 5C4471(R), 5C8310(R); Serial Numbers: All serial numbers

Source

Dataset: openFDA device recall enforcement reports
FDA record: This recall in openFDA (JSON)
Enforcement Report: Search FDA's Enforcement Report for Z-0939-2015
openFDA file date: Oct 27, 2026
Loaded by RegDataLab: Oct 29, 2026

These dates say when openFDA published the data file and when RegDataLab last loaded it.

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