VANTIVE US HEALTHCARE recalled 115,112 units of the PRISMAFLEX HF1000 SET on January 6, 2026. The recall stems from a 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 HF1000 SET is a medical device used in dialysis treatments, allowing patients to receive renal replacement therapy. Patients and healthcare providers rely on its functionality to ensure safe and effective dialysis procedures.
The risk of dislodgement from the control unit can interrupt the dialysis process, which is critical for patients with kidney failure. This malfunction could lead to serious health complications, making the product hazardous.
This recall is not part of a broader industry pattern.
The recall affects a large number of patients who depend on this medical device for regular dialysis treatments. Immediate action is necessary to ensure patient safety.
Product codes and model numbers can typically be found on the device packaging or the product itself.
Expect a timeline of approximately 4-6 weeks for refund or replacement processing after contacting the manufacturer.
Document all correspondence with the manufacturer, including emails and phone calls. Keep receipts and any return shipping information.
The recalled product is the PRISMAFLEX HF1000 SET, Product Code 107142. It includes all lots manufactured after 24F0094CA and has a UDI/DI of 07332414069315. The device was distributed nationwide in the United States.
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