PRISMAFLEX HF1000 SET, Product Code 107140; Dialyzer, High Permeability With Or Without Sealed Dialysate System
| Source | FDA Device Enforcement |
|---|---|
| Category | Medical Device |
| Severity | Medium |
| Status | ongoing |
| Recall date | January 06, 2026 |
| Reported | February 11, 2026 |
| Recalling firm | VANTIVE US HEALTHCARE LLC |
| Country / region | United States IL |
Hazard
There is a potential dislodgement of the Prismaflex Set deaeration chamber from the Prismaflex Control Unit.
Affected products
- PRISMAFLEX HF1000 SET, Product Code 107140; Dialyzer, High Permeability With Or Without Sealed Dialysate System
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