VANTIVE US Healthcare recalled 137,576 Prismaflex M150 Sets on January 6, 2026. The recall addresses a risk of dislodgement of the deaeration chamber from the control unit. Healthcare providers and patients should stop using the device immediately and follow recall instructions.
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 M150 Set is a medical device used in dialysis treatment for patients with kidney failure. It facilitates the removal of waste and excess fluid from the bloodstream during dialysis procedures.
The potential dislodgement of the deaeration chamber from the control unit can compromise the device's functionality, posing serious health risks to patients relying on dialysis treatment.
This recall is not part of a broader industry pattern.
Patients using the Prismaflex M150 Set may face serious health risks if the device malfunctions during treatment, highlighting the urgency for immediate action.
The product code and UDI/DI number can typically be found on the packaging or the product label itself.
Expect the refund or replacement process to take approximately 4-8 weeks from the time your request is processed.
Keep a record of all communication with VANTIVE US Healthcare, including emails, letters, and phone call notes.
The recalled product is the Prismaflex M150 Set, Product Code 109990, with UDI/DI 07332414090005. The recall affects all lots manufactured after 24F0100CA. The devices were distributed nationwide in the U.S.
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