Prismaflex Hf1000 Set, Product Code 107140; Dialyzer, High Permeability With Or Without Sealed Dialysate System
Recall Summary Baxter is recalling PRISMAFLEX HF1000 SET (Product Code 107140) dialyzers because the deaeration chamber may become loose and separate from the control unit during use. This recall affects dialysis patients who use this equipment. The company has classified this as a Class II recall, meaning the problem could cause serious health issues but is not immediately life-threatening.
- Recalling firm
- VANTIVE US HEALTHCARE LLC
- Product
- PRISMAFLEX HF1000 SET, Product Code 107140; 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/94e389cf-874c-49c9-b494-9d6e8d03761c