VANTIVE US HEALTHCARE recalled 87,436 Prismaflex ST100 Dialyzers on January 6, 2026. The recall follows reports of potential dislodgement of the deaeration chamber from the control unit. Healthcare providers and patients must stop using the device immediately.
There is a potential dislodgement of the Prismaflex Set deaeration chamber from the Prismaflex Control Unit.
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact VANTIVE US HEALTHCARE LLC or your healthcare provider for instructions. Notification method: Letter
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The Prismaflex ST100 Dialyzer is a medical device used in dialysis treatments for patients with kidney failure. It helps filter waste and excess fluids from the blood, making it critical for patient health.
The potential dislodgement of the deaeration chamber can disrupt the functioning of the dialysis system, which may result in inadequate treatment for the patient.
This recall is not part of a broader industry pattern.
Patients relying on this device for safe and effective dialysis are at risk if the device malfunctions. Immediate action is necessary to prevent potential health complications.
Product codes and model numbers are typically located on the packaging or the device itself.
Expect a response from VANTIVE US HEALTHCARE regarding the recall within a few weeks after reporting.
Keep records of your device's serial numbers, any correspondence with the manufacturer, and receipts if applicable.
The recalled product is the Prismaflex ST100 Set US, Product Code 107636US. It has been distributed nationwide in the U.S. and was sold in various healthcare facilities.
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