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FDA-Device2026-02-11Class IIPROCESSING DEFECT

Vantive Prismaflex HF1000 dialyzer set recalled for deaeration chamber dislodgement

Vantive
OTHERNationwide distribution

Stop using affected Prismaflex HF1000 dialyzer sets

The deaeration chamber in certain Prismaflex HF1000 dialyzer sets may become loose or detached from the Prismaflex Control Unit during use. This could affect the proper function of the dialysis equipment. The recall affects units manufactured on or after lot 24F0094CA.

  • Check your Prismaflex HF1000 set lot number (24F0094CA or later) against the product code 107142
  • Stop using affected sets immediately
  • Contact your healthcare facility or Vantive US Healthcare for replacement instructions
  • Do not use the equipment until you receive guidance from your provider
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-1230-2026

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