Recall Z-0291-2016 ยท FKX System, Peritoneal, Automatic Delivery
Baxter Healthcare Corp.
Baxter HomeChoice and HomeChoice Pro APD systems, designed to provide Automated Peritoneal Dialysis (APD) therapy for pediatric and adult renal patients.
| Date | Nov 17, 2015 (initiated Jun 29, 2015) |
| Status | Terminated |
| Reason | Loud operating sounds, which was unacceptable to the end users when the device was powered on. The HomeChoice devices continue to perform as intended, as the issue is only associated with the noise coming from the device and not the function of it. May delay treatment if changing to a different system. |
| Root cause | Device Design |
| Action | Baxter sent an Important Product Information communication to affected customers (patients and clinicians) via U.S.P.S., first-class mail on June 29, 2015. The letter states that Baxter Healthcare Corporation is updating the HomeChoice Patient At-Home Guide to include a discussion of the expected operating sounds associated with the HomeChoice and HomeChoice PRO devices. The new labeling will address the following: The HomeChoice cycler utilizes an air (pneumatic) pump; some sounds related to the operation of this pump are expected as part of normal operation of the HomeChoice cycler. There wi |
| Quantity | 29355 |
| Distribution | Nationwide Distribution, District of Columbia, and Puerto Rico. |
| 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 |