VANTIVE US HEALTHCARE recalled 13,760 Prismaflex TPE2000 Sets on January 6, 2026, due to a potential dislodgement hazard. The recall affects the deaeration chamber of the Prismaflex 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 TPE2000 Set is a medical device used in dialysis treatments. Healthcare providers and patients rely on this product for its high permeability features in managing patients' renal health.
The hazard arises from the potential dislodgement of the deaeration chamber from the control unit, which could disrupt the dialysis process and pose serious health risks to patients.
This recall is not part of a broader industry pattern.
Patients using the Prismaflex TPE2000 Set may face serious health risks if the device malfunctions. The urgency of the recall requires immediate action to ensure patient safety.
Look for the product code on the packaging and the device itself, typically located on a label or barcode.
Allow 4-6 weeks for processing refunds or replacements after following the recall instructions.
Keep copies of correspondence with the manufacturer, receipts, and any related medical records.
The recalled product is the Prismaflex TPE2000 Set, Product Code 114093. It includes models UDI/DI 07332414111038 and all lots manufactured after 24J0106. The product was distributed nationwide in the U.S.
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