VANTIVE US HEALTHCARE LLC recalls PRIMSAFLEX M100 SET
- Recalling company
- VANTIVE US HEALTHCARE LLC
- Product
- PRIMSAFLEX M100 SET, Product Code 106697; 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 – may cause temporary or medically reversible health consequences
- Recall date
- Jan 6, 2026
- Reported
- Feb 11, 2026
- Distribution
- US Nationwide distribution.
- Status
- Ongoing
- Quantity
- 230,596 units
- Lot / codes
- UDI/DI 07332414064556, All lots including and manufactured after 24F0077CA
- Company location
- Deerfield, IL
- Recall type
- Voluntary: Firm initiated
- Recall number
- Z-1227-2026
- Agency
- U.S. Food and Drug Administration (FDA)
View official FDA notice ↗ Search recall number Z-1227-2026 in the FDA Enforcement Report. Also see FDA recall press releases.
If you use this product, check the lot, NDC or model number against the official notice and follow its instructions. Do not stop a prescribed medicine or remove a medical device without talking to your doctor or pharmacist. Report problems to FDA MedWatch. FoodRecallNow summarizes public FDA data and is not medical advice.