Recall Z-1245-2015 ยท FIK System, Dialysate Delivery, Recirculating
Baxter Healthcare Corp.
AMIA v1.0 APD System. For Automated Peritoneal Dialysis (APD) therapy for pediatric and adult renal patients.
| Date | Mar 4, 2015 (initiated Apr 3, 2014) |
| Status | Terminated |
| Reason | Additional warning in the AMIA APD System labeling for patients vulnerable to unintended Increased Intraperitoneal Volume (IIPV), also known as overfill. The patients include neonates, infants, small children, and any patient with significant heart and/or lung disease. |
| Root cause | Error in labeling |
| Action | Baxter sent IMPORTANT PRODUCT INFORMATION letters dated April 3, 2014 to all peritoneal dialysis healthcare providers of record. The letters advised healthcare providers of the potential to develop Increased Intraperitoneal Volume (IIPV) and instructed the healthcare providers to complete and return the attached Customer Reply Form. Healthcare providers with clinical questions can contact Baxter's Renal Division Clinical Helpline at 888-736-2543, option 2, 8:00 AM - 5:00 PM CT. Healthcare providers with general questions can contact The Center for One Baxter by telephone at 800-422-9837, Monda |
| Quantity | 55 systems |
| Distribution | US: Nationwide in the states of (GA, MA, NC, NY, PA, WA) |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K102936 | HOMECHOICE/HOMECHOICE PRO AUTOMATED PERSONAL CYCLER PERITONEAL DIALYSIS SYSTEM MODEL 5C4471, 5C8310, 5C4471R AND 5C8310R Baxter Healthcare Corp, Mar 30, 2011 |