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FDA-Device2026-02-11Class IIPROCESSING DEFECT

Vantive Prismaflex TPE2000 dialysis set recalled for deaeration chamber dislodgement risk

Vantive
OTHERNationwide distribution

Stop using affected Vantive Prismaflex TPE2000 sets

Vantive US Healthcare is recalling certain Prismaflex TPE2000 dialysis sets because the deaeration chamber may detach from the Prismaflex Control Unit during use. This could interrupt dialysis treatment. The recall affects units manufactured on or after June 2024.

  • Check if your dialysis unit uses a Prismaflex TPE2000 set with Product Code 114093 and UDI/DI 07332414111038
  • Contact your healthcare provider or dialysis center immediately if you have one of these sets
  • Do not use the affected set until your provider instructs you
Hazard

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

Sold states
US Nationwide distribution.
Affected count
13,760 units
Manufactured in
510 Lake Cook Rd, N/A, Deerfield, IL, United States
Products
PRISMAFLEX TPE2000 SET, Product Code 114093; Dialyzer, High Permeability With Or Without Sealed Dialysate System

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1231-2026

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