Vantive US Healthcare is recalling over 944,000 Prismaflex dialysis sets because the deaeration chamber can potentially detach from the control unit during use. This issue affects multiple product lines including Prismaflex ST, Oxiris, M, HF, and TPE sets manufactured throughout 2024. If the chamber dislodges, it can disrupt the continuous renal replacement therapy required by critically ill patients.
Dislodgement of the deaeration chamber can cause blood leaks, air entry into the circuit, or therapy interruption. This poses a risk of significant blood loss or inadequate treatment for patients undergoing dialysis or blood filtration.
Dialyzer, High Permeability With Or Without Sealed Dialysate System
Dialyzer, High Permeability With Or Without Sealed Dialysate System
Dialyzer, High Permeability With Or Without Sealed Dialysate System
Dialyzer, High Permeability With Or Without Sealed Dialysate System
Dialyzer, High Permeability With Or Without Sealed Dialysate System
Dialyzer, High Permeability With Or Without Sealed Dialysate System
Dialyzer, High Permeability With Or Without Sealed Dialysate System
Dialyzer, High Permeability With Or Without Sealed Dialysate System
If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.
This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.
AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.
Sources: FDA iRES · Raw API Response
openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.