VANTIVE US Healthcare recalled 230,596 units of the PRIMSAFLEX M100 Set on January 6, 2026. The recall follows a risk of 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 recall involves the PRIMSAFLEX M100 Set, Product Code 106697, which includes all lots manufactured after 24F0077CA. The product is distributed nationwide in the United States.
The potential dislodgement of the deaeration chamber poses a serious risk to patients relying on this medical device for dialysis treatment. This hazard falls under the Class II recall classification.
As of now, there are no reported injuries or incidents related to this device dislodgement. The issue has been identified before any adverse events occurred.
Patients and healthcare providers should stop using the device immediately. Contact VANTIVE US HEALTHCARE LLC or your healthcare provider for further instructions.
For more information, contact VANTIVE US HEALTHCARE at [insert phone number] or visit their website.
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