Recall Z-0932-2015 ยท FKX System, Peritoneal, Automatic Delivery
Baxter Healthcare Corp.
Baxter Amia Automated PD systems are used in the treatment of adult renal failure patients to perform automated peritoneal dialysis.
| Date | Jan 7, 2015 (initiated Apr 24, 2014) |
| Status | Terminated |
| Reason | System error 01779 is produced when the battery cannot be charged due to specific voltage differences between the battery and the charger. |
| Root cause | Under Investigation by firm |
| Action | Baxter sent an IMPORTANT PRODUCT INFORMATION letter dated April 24, 2014 to all affected customers. The peritoneal dialysis provider consignees were instructed to: 1) complete the enclosed customer reply form and return it to Baxter; and, 2) contact Baxter Technical Services at 800-553-6898 should a System Event 01179 occur. Baxter Technical Services is available 24 hours a day, 7 days a week. Clinical questions can be directed to Baxter's Renal Clinical Helpline at 888-736-2543, option 2 (Monday - Friday, 8:00 AM - 5:00 PM CT). General questions regarding the Import Product Information let |
| Quantity | 55 units |
| Distribution | Nationwide Distribution including GA, MA, NC, NY, PA, and WA. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K124018 | AMIA AUTOMATED PD SYSTEM Deka Research & Development Corp., Jun 14, 2013 |