VANTIVE US Healthcare recalled 230,596 units of the PRIMSAFLEX M100 Set on January 6, 2026. The recall follows a risk of 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 PRIMSAFLEX M100 Set is a medical device used in dialysis treatment, providing high permeability for effective filtration. Patients purchase these devices to manage kidney failure and ensure proper blood filtration during treatment.
The potential dislodgement of the deaeration chamber can disrupt the dialysis process, posing serious risks to patient health. This malfunction could lead to inadequate treatment and potential medical complications.
This recall is not part of a broader industry pattern.
This recall requires immediate action from patients and healthcare providers to prevent potential health risks. The urgency stems from the need for safe and effective dialysis treatment.
The product code and model number are typically located on the packaging and the device itself.
Expect further instructions regarding the refund or replacement process within 4-8 weeks after contacting the manufacturer.
Keep records of your purchase, any communications with the manufacturer, and a copy of the recall notification for your files.
The recall involves the PRIMSAFLEX M100 Set, Product Code 106697, which includes all lots manufactured after 24F0077CA. The product is distributed nationwide in the United States.
Not sure what to do next? Our guide walks you through the process step by step.
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