Primsaflex M100 Set, Product Code 106697; Dialyzer, High Permeability With Or Without Sealed Dialysate System
Recall Summary Vantive US Healthcare is recalling the PRIMSAFLEX M100 SET (Product Code 106697), a dialyzer used in blood filtration treatment, because the deaeration chamber may become loose or detach from the control unit during use. This is a Class II recall, meaning there is potential for serious adverse health effects. The recall affects patients using this dialysis equipment.
- Recalling firm
- VANTIVE US HEALTHCARE LLC
- Product
- PRIMSAFLEX M100 SET, Product Code 106697; 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/1351727f-b54b-48d6-8f2c-4d3ab5fee562