PRISMAFLEX ST100 SET US, Product Code 107636US; Dialyzer, High Permeability With Or Without Sealed Dialysate System
Reported: February 11, 2026 Initiated: January 6, 2026 #Z-1224-2026
Product Description
PRISMAFLEX ST100 SET US, Product Code 107636US; Dialyzer, High Permeability With Or Without Sealed Dialysate System
Reason for Recall
There is a potential dislodgement of the Prismaflex Set deaeration chamber from the Prismaflex Control Unit.
Details
- Recalling Firm
- VANTIVE US HEALTHCARE LLC
- Units Affected
- 87,436 units
- Distribution
- US Nationwide distribution.
- Location
- Deerfield, IL
Frequently Asked Questions
What product was recalled? ▼
PRISMAFLEX ST100 SET US, Product Code 107636US; Dialyzer, High Permeability With Or Without Sealed Dialysate System. Recalled by VANTIVE US HEALTHCARE LLC. Units affected: 87,436 units.
Why was this product recalled? ▼
There is a potential dislodgement of the Prismaflex Set deaeration chamber from the Prismaflex Control Unit.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on February 11, 2026. Severity: Moderate. Recall number: Z-1224-2026.
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