Dialysis connectivity software recalled because prescription changes may not reach cyclers
Vantive is recalling the Sharesource Connectivity Platform for Homechoice Claria because a software defect may stop updated prescription settings from saving on the patient's cycler.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: Scored 3 under the risk-of-harm criterion: a patient may receive outdated dialysis therapy while the clinician sees a correct prescription, and no injuries are reported.
Plain-English summary
The Sharesource Connectivity Platform for use with Homechoice Claria, product code 5CGM01, is being recalled across software versions 7.13.3 (China), 8.13.2 (APAC and Korea) and 8.13.4 (US, EMEA and LATAM).
Vantive has identified a software defect within the Sharesource Claria software which may cause a patient's updated prescription program settings not to be properly saved on the cycler the patient is actually using for their therapy. As a result, the clinician may believe the patient is receiving the correct prescribed therapy because of what is displayed in the remote Sharesource application, when the cycler with the patient is delivering an outdated and incorrect therapy.
The product carries UDI-DI 15413765545723 and was distributed worldwide, including nationwide in the United States and to Australia, Hong Kong, Korea, New Zealand and Taiwan. The FDA has classified the action as Class II.
The enforcement record reports no injuries. Clinicians and patients using the affected software should follow Vantive's instructions and confirm prescription settings on the cycler itself.
The recalled product
- 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)
- Manufacturer
- Vantive US Healthcare LLC
- Affected units
- 1
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (5)
- UDI-DI 15413765545723 software versions 7.13.3 (China)
- 8.13.2 (APAC and Korea)
- and 8.13.4 (US
- EMEA
- and LATAM)
Distribution
Distributed nationwide across the United States.
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