Recall Z-1231-2026— VANTIVE US HEALTHCARE LLC
Class II · Ongoing
Class II FDA medical device recall by VANTIVE US HEALTHCARE LLC, initiated 2026-01-06. FDA's recall record names no specific 510(k) clearance for this event. Product: PRISMAFLEX TPE2000 SET, Product Code 114093; 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..
- Recalling firm
- VANTIVE US HEALTHCARE LLC
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2026-01-06
- Firm location
- Deerfield, IL, United States
Product description
PRISMAFLEX TPE2000 SET, Product Code 114093; 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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.