HomeChoice/HomeChoice Pro Automated Personal Cycler, for Automated Peritoneal Dialysis. Product codes 5C8310, 5C8310R, R
FDA device recall Z-1031-2015 · posted 2015-01-29 · Terminated
Recall details
- Recalling firm
- Baxter Healthcare Corp.
- Reason for recall
- The keypad buttons on HomeChoice devices may be activated without the operator pressing them.
- 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.
- Root cause
- Nonconforming Material/Component
- Status
- Terminated
- Product code
- FKX
- Quantity affected
- 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
- Date initiated
- 2014-10-21
- Date posted
- 2015-01-29
- Date terminated
- 2015-09-01
- Location
- Deerfield, IL
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| HOMECHOICE/HOMECHOICE PRO AUTOMATED PERSONAL CYCLER PERITONEAL DIALYSIS SYSTEM MODEL 5C4471, 5C8310, 5C4471R AND 5C8310R (K102936) | Baxter Healthcare Corp | 2011-03-30 |