Recall Z-1056-2017 ยท FKX System, Peritoneal, Automatic Delivery
Baxter Healthcare Corporation
APD Set with Cassette 3-Prong Peritoneal Dialysis Set Indicated for use in the treatment of patients with renal failure to provide PD fluid exchanges with Baxter HomeChoice PD systems in clinical and home use settings.
| Date | Jan 19, 2017 (initiated Dec 16, 2016) |
| Status | Terminated |
| Reason | Customer complaints received for the presence of leaks |
| Root cause | Device Design |
| Action | An Urgent Product Recall communication will be sent to affected customers via U.S.P.S., first class mail. |
| Quantity | 8640 eaches |
| Distribution | US only |
| 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 |