Class II — VANTIVE US HEALTHCARE LLC
| Recalling firm | Vantive US Healthcare LLC |
|---|---|
| Registered facility | View this company's 16 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class II |
| Status | Ongoing |
| Reason | There is a potential dislodgement of the Prismaflex Set deaeration chamber from the Prismaflex Control Unit. |
| Product | PRISMAFLEX HF1000 SET, Product Code 107142; Dialyzer, High Permeability With Or Without Sealed Dialysate System |
| Quantity | 115,112 units |
| Distribution | US Nationwide distribution. |
| Initiated | 2026-01-06 |
| Classified | 2026-02-02 |
| Recall number | Z-1230-2026 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — VANTIVE US HEALTHCARE LLC (Z-1230-2026).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/98180/
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