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FDA-Device2026-02-11Class IIPROCESSING DEFECT

Vantive Prismaflex ST100 dialyzer set recalled for deaeration chamber dislodgement risk

Vantive
OTHERNationwide distribution

Stop using affected Vantive Prismaflex ST100 sets

The deaeration chamber in certain Vantive Prismaflex ST100 dialyzer sets may detach from the control unit during use. This could interrupt treatment. The recall affects units manufactured on or after lot 24G0072.

  • Stop using Prismaflex ST100 sets with lot number 24G0072 or later
  • Contact your dialysis provider or Vantive immediately to report which lots your facility uses
  • Request replacement sets or use alternative products until your supply is confirmed safe
  • Follow your healthcare provider's guidance on treatment continuity during the transition
Hazard

There is a potential dislodgement of the Prismaflex Set deaeration chamber from the Prismaflex Control Unit.

Sold states
US Nationwide distribution.
Affected count
87,436 units
Manufactured in
510 Lake Cook Rd, N/A, Deerfield, IL, United States
Products
PRISMAFLEX ST100 SET US, Product Code 107636US; Dialyzer, High Permeability With Or Without Sealed Dialysate System

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1224-2026

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