Vantive US Healthcare LLC recalls Sharesource Connectivity Platform for Use with Homechoice Claria Product Code 5CGM01 s

Recalling company

Vantive US Healthcare LLC

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clinician's remote Sharesource application, when in fact the cycler that is with the patient is actually delivering an outdated and incorrect therapy.

Classification

Class II – may cause temporary or medically reversible health consequences

Recall date

Aug 28, 2025

Reported

Nov 5, 2025

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.

Status

Ongoing

Quantity

1

Lot / codes

UDI-DI 15413765545723 software versions 7.13.3 (China), 8.13.2 (APAC and Korea), and 8.13.4 (US, EMEA, and LATAM)

Company location

Deerfield, IL

Recall type

Voluntary: Firm initiated

Recall number

Z-0409-2026

Agency

U.S. Food and Drug Administration (FDA)

View official FDA notice ↗ Search recall number Z-0409-2026 in the FDA Enforcement Report. Also see FDA recall press releases.