VANTIVE US Healthcare recalled 93,576 Prismaflex HF1000 Sets on January 6, 2026. The recall addresses a potential dislodgement of the deaeration chamber from the control unit. Healthcare providers and patients must stop using the device immediately and follow provided 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 HF1000 Set is a medical device used in dialysis treatments. Patients and healthcare providers purchase this product for its high permeability to ensure efficient blood filtration during procedures.
The risk of dislodgement of the deaeration chamber from the control unit can lead to serious complications during dialysis. This malfunction may interrupt treatment and compromise patient safety.
This recall is not part of a broader industry pattern.
Patients relying on this device must stop using it immediately, which can disrupt their treatment. This recall requires urgent attention to prevent potential health risks.
The model number and product code can typically be found on the product packaging or on the device itself.
Expect a processing time of 4-6 weeks for refunds or replacements after the recall instructions are followed.
Document all communications with the manufacturer and keep a copy of recall notices and any receipts related to the device.
The recalled product is the Prismaflex HF1000 Set, Product Code 107140. It has UDI/DI 07332414069254 and includes all lots manufactured after 24G0034CA. The product was distributed nationwide in the U.S.
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