Z-1031-2015 Class II Terminated
FDA device recall Z-1031-2015 was initiated by Baxter Healthcare Corp. on Oct 21, 2014 and is designated Class II. Reason for recall: The keypad buttons on HomeChoice devices may be activated without the operator pressing them. The recall status is terminated (terminated Sep 1, 2015). Affected quantity: 200.
Recall Details
- Product Type
- Devices
- Report Date
- Feb 4, 2015
- Initiation Date
- Oct 21, 2014
- Termination Date
- Sep 1, 2015
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 200
Product Description
HomeChoice/HomeChoice Pro Automated Personal Cycler, for Automated Peritoneal Dialysis. Product codes 5C8310, 5C8310R, R5C8320, and 5C4474.
Reason for Recall
The keypad buttons on HomeChoice devices may be activated without the operator pressing them.
Distribution Pattern
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
Code Information
all codes distributed between 4/15/2014 and 6/11/2014
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1031-2015
- openFDA file date
- Oct 27, 2026
- Loaded by RegDataLab
- Oct 29, 2026