FDAHealthJanuary 6, 2026
VANTIVE US HEALTHCARE LLC — PRIMSAFLEX M100 SET, Product Code 106697; Dialyzer, High Permeability With Or Without Sealed Dialysate System
⚠️ There is a potential dislodgement of the Prismaflex Set deaeration chamber from the Prismaflex Control Unit.
Is this relevant to me?
- Geography
- Nationwide
- Source agency
- FDA
- Category
- Health
- Published
- January 6, 2026
US Nationwide distribution.
What's affected?
- Product
- PRIMSAFLEX M100 SET, Product Code 106697; Dialyzer, High Permeability With Or Without Sealed Dialysate System
- Lot code
- including
Additional details
UDI/DI 07332414064556, All lots including and manufactured after 24F0077CA
What should I do?
Recommended action
Class II recall. Voluntary: Firm initiated Quantity affected: 230,596 units.
Get Health recall alerts
Delivered to your inbox. Free. No account required.