FDA-Device2026-02-11Class II
PRISMAFLEX HF1000 SET, Product Code 107142; Dialyzer, High Permeability With Or Without Sealed Dialysate System
VANTIVE US HEALTHCARE LLC
Hazard
There is a potential dislodgement of the Prismaflex Set deaeration chamber from the Prismaflex Control Unit.
Sold states
US Nationwide distribution.
Affected count
115,112 units
Manufactured in
510 Lake Cook Rd, N/A, Deerfield, IL, United States
Products
PRISMAFLEX HF1000 SET, Product Code 107142; Dialyzer, High Permeability With Or Without Sealed Dialysate System
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1230-2026Don't want to check this manually?
We email you a Sunday digest of new federal recalls relevant to parents — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.
Get the Sunday Brief