VANTIVE US HEALTHCARE recalled 13,760 Prismaflex TPE2000 Sets on January 6, 2026, due to a potential dislodgement hazard. The recall affects the deaeration chamber of the Prismaflex 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 TPE2000 Set, Product Code 114093. It includes models UDI/DI 07332414111038 and all lots manufactured after 24J0106. The product was distributed nationwide in the U.S.
The recall is due to a potential dislodgement of the Prismaflex Set deaeration chamber from the Prismaflex Control Unit. This poses a high risk to patient safety, as improper functioning could lead to serious health complications.
The recall does not report any specific incidents or injuries associated with this issue. However, the potential for dislodgement indicates a high hazard level.
Patients and healthcare providers should stop using the Prismaflex TPE2000 Set immediately. Follow the recall instructions provided by VANTIVE US HEALTHCARE. For further guidance, contact your healthcare provider.
For more information, contact VANTIVE US HEALTHCARE LLC. Visit the FDA's website for detailed recall instructions.
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