HomeChoice/HomeChoice Pro Automated Personal Cycler, for Automated Peritoneal Dialysis. Product codes 5C8310, 5C8310R, R5C8320, and 5C4474.
This recall has been terminated (originally issued January 29, 2015).
- Company
- Baxter Healthcare Corp.
- Recall Initiated
- October 21, 2014
- Posted
- January 29, 2015
- Terminated
- September 1, 2015
- Recall Number
- Z-1031-2015
- Quantity
- 200
- Firm Location
- Deerfield, IL
- Official Source
- View on FDA website ↗
Reason for Recall
The keypad buttons on HomeChoice devices may be activated without the operator pressing them.
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 / Code Info
all codes distributed between 4/15/2014 and 6/11/2014
Root Cause
Nonconforming Material/Component
Action Taken
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.