VANTIVE US HEALTHCARE recalled 2,724 OXIRIS SET dialyzers on January 6, 2026. The recall follows reports of potential dislodgement of the deaeration chamber from the Prismaflex Control Unit. Patients and healthcare providers 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 OXIRIS SET is a medical device used in dialysis treatments. Patients rely on it for effective filtration of blood during kidney replacement therapy.
The defect can potentially dislodge the deaeration chamber, which could disrupt the dialysis process and lead to serious health risks.
This recall is not part of a broader industry pattern.
Patients using the OXIRIS SET must stop its use immediately, which may cause inconvenience and require alternative arrangements for dialysis.
Look for the product code and UDI number on the packaging or the device itself.
Expect processing for refunds or replacements to take approximately 4-6 weeks.
Keep a record of your purchase, including receipts, and document any communications with the manufacturer.
The recall affects the OXIRIS SET, Product Code 112016, which includes models with UDI/DI 07332414102234. The product was 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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