[pending] PRISMAFLEX M150 SET, Product Code 109990; Dialyzer, High Permeability With Or Without Sealed Dialysa
Pending LLM rewrite. Source: FDA_DEVICE Z-1228-2026.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: Pending LLM scoring against the rubric.
Plain-English summary
There is a potential dislodgement of the Prismaflex Set deaeration chamber from the Prismaflex Control Unit.
The recalled product
- Product
- PRISMAFLEX M150 SET, Product Code 109990; 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 07332414090005
- All lots including and manufactured after 24F0100CA
Distribution
Distributed nationwide across the United States.
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