Prismaflex St100 Set Us, Product Code 107636us; Dialyzer, High Permeability With Or Without Sealed Dialysate System
Recall Summary VANTIVE US HEALTHCARE LLC is recalling PRISMAFLEX ST100 SET US (Product Code 107636US) dialyzers because the deaeration chamber may become dislodged from the control unit during use. This is a Class II recall affecting users of this dialysis equipment.
- Recalling firm
- VANTIVE US HEALTHCARE LLC
- Product
- PRISMAFLEX ST100 SET US, Product Code 107636US; 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/ee27d427-704b-47e7-a60e-ac79df68f32e