PRISMAFLEX HF1000 SET, Product Code 107140; Dialyzer, High Permeability With Or Without Sealed Dialy
Pending LLM rewrite. Source: FDA_DEVICE Z-1229-2026.
Severity not yet assessed
We have not scored this recall against our rubric yet, so we are not showing a severity rating or our usual guidance. The agency’s own notice below is the authoritative source — read it first.
Plain-English summary
There is a potential dislodgement of the Prismaflex Set deaeration chamber from the Prismaflex Control Unit.
The recalled product
- Product
- PRISMAFLEX HF1000 SET, Product Code 107140; Dialyzer, High Permeability With Or Without Sealed Dialysate System
- Manufacturer
- VANTIVE US HEALTHCARE LLC
- Category
- Medical Device — Devices
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- UDI/DI 07332414069254
- All lots including and manufactured after 24G0034CA
Distribution
Distributed nationwide across the United States.
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