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U.S. Department of Health and Human Services

Class 2 Device Recall Sharesource

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 Class 2 Device Recall Sharesourcesee related information
Date Initiated by FirmAugust 28, 2025
Date PostedOctober 29, 2025
Recall Status1 Open3, Classified
Recall NumberZ-0409-2026
Recall Event ID 97527
510(K)NumberK201867 
Product Classification System, peritoneal, automatic delivery - Product Code FKX
ProductSharesource 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)
Code Information UDI-DI 15413765545723 software versions 7.13.3 (China), 8.13.2 (APAC and Korea), and 8.13.4 (US, EMEA, and LATAM)
Recalling Firm/
Manufacturer		 Vantive US Healthcare LLC
1 Baxter Pkwy Bldg 6
Deerfield IL 60015-4625
For Additional Information ContactVantive customer service
800-284-4060
Manufacturer Reason
for Recall		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clinician's remote Sharesource application, when in fact the cycler that is with the patient is actually delivering an outdated and incorrect therapy.
FDA Determined
Cause 2		Software design
ActionClinics 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 programs.
Quantity in Commerce1
DistributionWorldwide 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.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database510(K)s with Product Code = FKX
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