Prismaflex Tpe2000 Set, Product Code 114093; Dialyzer, High Permeability With Or Without Sealed Dialysate System
Recall Summary VANTIVE US HEALTHCARE LLC is recalling PRISMAFLEX TPE2000 SET (Product Code 114093) dialyzers because the deaeration chamber may become loose or separate from the control unit during use. This recall affects medical facilities and patients using this dialysis equipment.
- Recalling firm
- VANTIVE US HEALTHCARE LLC
- Product
- PRISMAFLEX TPE2000 SET, Product Code 114093; 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 III
- 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/f66e8610-8732-4073-8713-1ca0ff3128c5