Reported Feb 11, 2026 · Ongoing
PRISMAFLEX HF1000 SET, Product Code 107142; Dialyzer, High Permeability With Or Without Sealed Dialysate System
Vantive US Healthcare LLC
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: VANTIVE US HEALTHCARE LLC · 510 Lake Cook Rd · Deerfield, IL · 60015-4964
Is this the product you have?
- PRISMAFLEX HF1000 SET, Product Code 107142; Dialyzer, High Permeability With Or Without Sealed Dialysate System
- Lot codes and dates
- UDI/DI 07332414069315, All lots including and manufactured after 24F0094CA
- Amount recalled
- 115,112 units
This recall covers 8 products
The agency filed one notice per product. You are reading one of them; the other 7 are below.
Where it was sold
- Nationwide
Why it was recalled
There is a potential dislodgement of the Prismaflex Set deaeration chamber from the Prismaflex Control Unit.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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