VANTIVE US HEALTHCARE recalled 87,436 Prismaflex ST100 Dialyzers on January 6, 2026. The recall follows reports of 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 recalled product is the Prismaflex ST100 Set US, Product Code 107636US. It has been distributed nationwide in the U.S. and was sold in various healthcare facilities.
The potential dislodgement of the deaeration chamber poses a serious risk to patients undergoing treatment. This defect could lead to improper functioning of the dialysis system, which may jeopardize patient safety.
There have been no specific reported injuries or deaths associated with this recall. However, the risk level is classified as high due to the critical nature of the device.
Patients and healthcare providers should immediately stop using the Prismaflex ST100 Dialyzer. For further instructions, contact VANTIVE US HEALTHCARE LLC or consult your healthcare provider.
For additional information, call VANTIVE US HEALTHCARE LLC at 1-800-XXX-XXXX or visit their website. More details are available at the FDA recall notice.
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