VANTIVE US HEALTHCARE LLC
What this record is not
A recall record is reproduced as FDA published it, and the classification is FDA’s. SPEQ adds no interpretation, and a recall concerns the products and dates in the record — it is not a statement about a company’s other products or its current status.
There is a potential dislodgement of the Prismaflex Set deaeration chamber from the Prismaflex Control Unit.
PRIMSAFLEX M100 SET, Product Code 106697; Dialyzer, High Permeability With Or Without Sealed Dialysate System
UDI/DI 07332414064556, All lots including and manufactured after 24F0077CA
Data: U.S. FDA. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification. Open the enforcement explorer →