Oxiris Set, Product Code 112016; Dialyzer, High Permeability With Or Without Sealed Dialysate System
Recall Summary VANTIVE US HEALTHCARE LLC is recalling the OXIRIS SET (Product Code 112016), a dialyzer used in blood filtration treatment. The deaeration chamber in the device may become loose or separate from the control unit during use. This recall affects patients who use this specific dialyzer product.
- Recalling firm
- VANTIVE US HEALTHCARE LLC
- Product
- OXIRIS SET, Product Code 112016; 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/05e59fc9-af7d-4268-9f78-76d8083c66ad