VANTIVE US Healthcare recalled 264,040 Prismaflex ST150 Dialyzers on January 6, 2026. The devices pose a high risk of the deaeration chamber dislodging from the control unit. Healthcare providers and patients must stop using these devices 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 ST150 SET US is a medical device used in dialysis treatment to filter waste from the blood. Patients require this type of equipment for routine kidney dialysis.
The risk of dislodgement poses a serious safety concern, as it may interrupt the dialysis process and endanger patient health. Immediate action is necessary to prevent potential complications.
This recall is not part of a broader industry pattern.
Patients relying on this device for dialysis may face significant health risks if the device malfunctions, necessitating immediate action and alternative arrangements.
Product codes are typically found on the device packaging or the device itself, often near the barcode or user manual.
Expect a refund or replacement process to take 4-8 weeks after the manufacturer processes your request.
Keep records of your purchase, any correspondence related to the recall, and photographs of the device.
The recalled product is the PRISMAFLEX ST150 SET US, Product Code 107640US. It includes all lots manufactured after 24F0085. The devices were distributed nationwide in the United States.
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