Recall Z-0409-2026 ยท FKX System, Peritoneal, Automatic Delivery
Vantive US Healthcare LLC
Sharesource Connectivity Platform for Use with Homechoice Claria Product Code 5CGM01 software versions 7.13.3 (China), 8.13.2 (APAC and Korea), and 8.13.4 (US, EMEA, and LATAM)
| Date | Oct 29, 2025 (initiated Aug 28, 2025) |
| Status | Open, Classified |
| Reason | Vantive has identified a software defect within the Sharesource Claria software, which may cause a patient s updated prescription program settings to not be properly saved on the actual cycler that the patient is using to perform their therapy. As a result, the clinician may think that the patient is receiving the correct prescribed therapy because of what is erroneously displayed on the clinician's remote Sharesource application, when in fact the cycler that is with the patient is actually delivering an outdated and incorrect therapy. |
| Root cause | Software design |
| Action | Clinics whose patients' programs were identified as being impacted by this issue were contacted by phone beginning 8/29/2025. Follow-up written notifications were sent out to all affected customers starting September 11, 2025. The Sharesource Claria software fix has been deployed and no further actions need to be taken by facilities who did not have directly affected patients. Note: If you have received the previous direct notification regarding a patient at your clinic, please note that Vantive will continue to be in touch with you regarding the next steps to correct those specific patient p |
| Quantity | 1 |
| Distribution | Worldwide distribution - US Nationwide and the countries of Australia, Hong Kong, Korea, New Zealand, Taiwan, Thailand, France, Germany, Ireland, Netherlands, Italy, Spain, Turkey, United Kingdom, Chile, and Colombia. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K201867 | Homechoice Claria APD System, Sharesource Connectivity Platform for Use with the Homechoice Claria APD System Baxter Healthcare Corporation, Nov 19, 2020 |