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 recall affects the OXIRIS SET, Product Code 112016, which includes models with UDI/DI 07332414102234. The product was distributed nationwide in the United States.
The recall addresses a high hazard risk due to potential dislodgement of the Prismaflex Set deaeration chamber from the Prismaflex Control Unit. This malfunction can lead to serious complications during dialysis.
Currently, there are no reported injuries or fatalities associated with this defect. The product is classified as Class II, indicating a potential risk.
Patients and healthcare providers should immediately stop using the affected devices. Follow the recall instructions provided by the manufacturer and contact VANTIVE US HEALTHCARE for further guidance.
For more information, contact VANTIVE US HEALTHCARE LLC. Visit their website or refer to the recall notification letter for instructions.
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