Prismaflex St150 Set Us, Product Code 107640us; Dialyzer, High Permeability With Or Without Sealed Dialysate System
Recall Summary VANTIVE US HEALTHCARE LLC is recalling the PRISMAFLEX ST150 SET US (Product Code 107640US) because the deaeration chamber may become loose and separate from the control unit during use. This is a Class II recall affecting dialysis equipment used in kidney treatment.
- Recalling firm
- VANTIVE US HEALTHCARE LLC
- Product
- PRISMAFLEX ST150 SET US, Product Code 107640US; 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/280ee225-fa19-4a15-a78d-491de370e8e8