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FDA-Device2026-02-11Class IIPROCESSING DEFECT

Vantive Prismaflex HF1000 dialyzer set recalled for deaeration chamber dislodgement risk

Vantive
OTHERNationwide distribution

Stop using affected Prismaflex HF1000 dialyzer sets

Vantive US Healthcare is recalling Prismaflex HF1000 dialyzer sets because the deaeration chamber may come loose from the Prismaflex Control Unit during use. This affects units manufactured on or after lot 24G0034CA. No injuries have been reported.

  • Check your Prismaflex HF1000 set lot number against lot 24G0034CA and later
  • Stop using affected units immediately
  • Contact Vantive US Healthcare or your healthcare provider for replacement units or instructions
  • Report any problems to the FDA MedWatch program
Hazard

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

Sold states
US Nationwide distribution.
Affected count
93,576 units
Manufactured in
510 Lake Cook Rd, N/A, Deerfield, IL, United States
Products
PRISMAFLEX HF1000 SET, Product Code 107140; Dialyzer, High Permeability With Or Without Sealed Dialysate System

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1229-2026

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