Prismaflex Hf1000 Set, Product Code 107142; Dialyzer, High Permeability With Or Without Sealed Dialysate System

Recall Summary Baxter is recalling the PRISMAFLEX HF1000 SET (Product Code 107142), a dialyzer used in blood filtration treatment, because the deaeration chamber may become loose and separate from the control unit during use. This is a Class II recall, meaning the product could cause serious health problems but is unlikely to result in death. The recall affects units distributed by VANTIVE US HEALTHCARE LLC.

Recalling firm

VANTIVE US HEALTHCARE LLC

Product

PRISMAFLEX HF1000 SET, Product Code 107142; Dialyzer, High Permeability With Or Without Sealed Dialysate System

Reason

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

Classification

Class II

Category

consumer product recall

Country

United States

Agency

FDA-DEVICES

Recall date

2026-01-06

Status

Open, Classified

Official recall notice from FDA-DEVICES

Recall details on Nibble Recalls: https://trynibble.app/recalls/44ad65f1-53ea-4967-8317-9eacaa0aae5a