VANTIVE US Healthcare recalled 137,576 Prismaflex M150 Sets on January 6, 2026. The recall addresses a risk of dislodgement of the deaeration chamber from the control unit. Healthcare providers and patients should stop using the device immediately and follow recall instructions.
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 M150 Set, Product Code 109990, with UDI/DI 07332414090005. The recall affects all lots manufactured after 24F0100CA. The devices were distributed nationwide in the U.S.
The hazard involves a potential dislodgement of the Prismaflex Set deaeration chamber from the Prismaflex Control Unit. This defect poses a high risk of malfunction during use, which could lead to serious health consequences for patients.
No specific incidents or injuries have been reported in connection with this recall. However, the potential for serious injury exists due to the malfunction.
Stop using the Prismaflex M150 Set immediately. Follow the instructions provided in the notification letter from VANTIVE US Healthcare and contact your healthcare provider for further guidance.
For questions or further instructions, contact VANTIVE US Healthcare LLC. Visit the FDA recall page for detailed information.
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