United StatesThe Sharesource Connectivity Platform for use with the Homechoice Claria cycler (Product Code 5CGM01, UDI-DI 15413765545723) running software versions 7.13.3 (China), 8.13.2 (APAC and Korea), or 8.13.4 (US, EMEA, and LATAM) is being recalled. Vantive identified a software defect that may prevent a patient’s updated prescription program settings from being saved on the cycler, causing the clinician’s remote Sharesource display to show the correct therapy while the patient’s cycler delivers an outdated, incorrect therapy.
What's being recalled
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)
Recalling firm: Vantive US Healthcare LLC, Deerfield, IL, United States.
How to identify it
UDI-DI 15413765545723 software versions 7.13.3 (China), 8.13.2 (APAC and Korea), and 8.13.4 (US, EMEA, and LATAM)
The hazard
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clinician's remote Sharesource application, when in fact the cycler that is with the patient is actually delivering an outdated and incorrect therapy.
What to do
Don't stop taking a prescribed medicine without talking to your doctor or pharmacist first. For other products, stop using them and ask the pharmacist, seller or maker what to do.
The notice doesn't give instructions for consumers, so this is general advice for health & beauty recalls. Check the official notice for the details.
Where it was sold
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.
The official notice
This page is a summary of the notice published by U.S. Food and Drug Administration (enforcement reports), collected from U.S. Food and Drug Administration (enforcement reports). Check the original before you act on it.
Read the official notice (opens in a new tab)