Prismaflex M150 Set, Product Code 109990; Dialyzer, High Permeability With Or Without Sealed Dialysate System
Recall Summary VANTIVE US HEALTHCARE LLC is recalling PRISMAFLEX M150 SET (Product Code 109990) and related high-permeability dialyzers because the deaeration chamber may come loose from the control unit during use. This is a Class II recall affecting dialysis patients who use this equipment.
- Recalling firm
- VANTIVE US HEALTHCARE LLC
- Product
- PRISMAFLEX M150 SET, Product Code 109990; 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/474bd4f2-514d-4815-ad77-430732f6cc37