United StatesPRISMAFLEX ST100 SET US (Product Code 107636US) and seven other Prismaflex/OXIRIS high‑permeability dialyzer sets listed with their product codes and UDIs — all lots including and manufactured after the specified lot numbers — are affected. They were recalled because the Prismaflex Set deaeration chamber can potentially become dislodged from the Prismaflex Control Unit.
What's being recalled
PRISMAFLEX ST100 SET US, Product Code 107636US; Dialyzer, High Permeability With Or Without Sealed Dialysate System
PRISMAFLEX ST150 SET US, Product Code 107640US; Dialyzer, High Permeability With Or Without Sealed Dialysate System
OXIRIS SET, Product Code 112016; Dialyzer, High Permeability With Or Without Sealed Dialysate System
PRIMSAFLEX M100 SET, Product Code 106697; Dialyzer, High Permeability With Or Without Sealed Dialysate System
PRISMAFLEX M150 SET, Product Code 109990; Dialyzer, High Permeability With Or Without Sealed Dialysate System
PRISMAFLEX HF1000 SET, Product Code 107140; Dialyzer, High Permeability With Or Without Sealed Dialysate System
PRISMAFLEX HF1000 SET, Product Code 107142; Dialyzer, High Permeability With Or Without Sealed Dialysate System
PRISMAFLEX TPE2000 SET, Product Code 114093; Dialyzer, High Permeability With Or Without Sealed Dialysate System
Recalling firm: Vantive US Healthcare LLC, Deerfield, IL, United States.
How to identify it
UDI/DI 00085412954073, All lots including and manufactured after 24G0072 UDI/DI 00085412917696, All lots including and manufactured after 24F0085 UDI/DI 07332414102234, All lots including and manufactured after 24G0041Z UDI/DI 07332414064556, All lots including and manufactured after 24F0077CA UDI/DI 07332414090005, All lots including and manufactured after 24F0100CA UDI/DI 07332414069254, All lots including and manufactured after 24G0034CA UDI/DI 07332414069315, All lots including and manufactured after 24F0094CA UDI/DI 07332414111038, All lots including and manufactured after 24J0106
The hazard
There is a potential dislodgement of the Prismaflex Set deaeration chamber from the Prismaflex Control Unit.
What to do
Don't stop taking a prescribed medicine without talking to your doctor or pharmacist first. For other products, stop using them and ask the pharmacist, seller or maker what to do.
The notice doesn't give instructions for consumers, so this is general advice for health & beauty recalls. Check the official notice for the details.
Where it was sold
US Nationwide distribution.
The official notice
This page is a summary of the notice published by U.S. Food and Drug Administration (enforcement reports), collected from U.S. Food and Drug Administration (enforcement reports). Check the original before you act on it.
Read the official notice (opens in a new tab)