Recall Z-1031-2015
Baxter Healthcare Corp. · initiated October 21, 2014
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
HomeChoice/HomeChoice Pro Automated Personal Cycler, for Automated Peritoneal Dialysis. Product codes 5C8310, 5C8310R, R5C8320, and 5C4474.
Codes / lots: all codes distributed between 4/15/2014 and 6/11/2014
Reason for recall
The keypad buttons on HomeChoice devices may be activated without the operator pressing them.
FDA-determined 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.
Details
- Recall number
- Z-1031-2015
- Initiated
- October 21, 2014
- Posted by FDA
- January 29, 2015
- Terminated
- September 1, 2015
- Product code
- FKX – System, Peritoneal, Automatic Delivery
- 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
- Recalling firm
- Baxter Healthcare Corp., Deerfield, IL