FDA Medical Device Recalls (openFDA)
Baxter Healthcare Corp.: HomeChoice/HomeChoice Pro Automated Personal Cycler, for Automated Peritoneal Dialysis. Product codes 5C8310, 5C8310R, R5C8320, and 5C4474.
- Recall number
- Z-1031-2015
- Recalling firm
- Baxter Healthcare Corp.
- Product
- HomeChoice/HomeChoice Pro Automated Personal Cycler, for Automated Peritoneal Dialysis. Product codes 5C8310, 5C8310R, R5C8320, and 5C4474.
- Status
- Terminated
- Initiated
- 2014-10-21
- Posted
- 2015-01-29
- Terminated
- 2015-09-01
- Reason
- The keypad buttons on HomeChoice devices may be activated without the operator pressing them.
- 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
- 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
- Lot, serial or model codes
- all codes distributed between 4/15/2014 and 6/11/2014
- 510(k) numbers
- ["K102936"]
- PMA numbers
- not on file
- Product code
- FKX
- Firm FEI
- 1417572
- Firm city
- Deerfield
- Firm state
- IL
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28