FDA Device recall Z-0409-2026
Sharesource Connectivity Platform for Use with Homechoice Claria Product Code 5CGM01 software versions 7.13.3 (China), 8.13.2 (APAC and Kor…
- FDA Device
- Class II
- ongoing
- Published 2025-11-05
On 2025-11-05 the FDA classified a Class II recall of Sharesource Connectivity Platform for Use with Homechoice Claria Product Code 5CGM01 software versions 7.13.3 (China), 8.13.2 (APAC and Kor… by Vantive Us Healthcare, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0409-2026 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2025-08-28 |
| Published | 2025-11-05 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Vantive Us Healthcare |
| Distribution | US |
Product
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)
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clinician's remote Sharesource application, when in fact the cycler that is with the patient is actually delivering an outdated and incorrect therapy.
Identifiers
| code_info | UDI-DI 15413765545723 software versions 7.13.3 (China), 8.13.2 (APAC and Korea), and 8.13.4 (US, EMEA, and LATAM) |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0409-2026%22
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