Prismaflex ST150 sets recalled over a deaeration chamber that may dislodge
Vantive US Healthcare is recalling 264,040 units of the PRISMAFLEX ST150 SET US because the Prismaflex Set deaeration chamber may dislodge from the Prismaflex Control Unit.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: Scored 2 because the record cites potential dislodgement of a component with no stated consequence or reported harm.
Plain-English summary
The PRISMAFLEX ST150 SET US, product code 107640US, a dialyzer, high permeability with or without sealed dialysate system, is being recalled by Vantive US Healthcare LLC.
The reason given in the enforcement record is a potential dislodgement of the Prismaflex Set deaeration chamber from the Prismaflex Control Unit.
The record lists 264,040 units under UDI/DI 00085412917696, covering all lots including and manufactured after 24F0085. Distribution was nationwide in the United States. The FDA has classified the action as Class II.
The record names no further consequence and reports no injuries. Facilities should follow Vantive's instructions.
The recalled product
- Product
- PRISMAFLEX ST150 SET US, Product Code 107640US; Dialyzer, High Permeability With Or Without Sealed Dialysate System
- Manufacturer
- VANTIVE US HEALTHCARE LLC
- Category
- Medical Device — Dialysis set
- Hazard
- component-dislodgement
- deaeration-chamber
- dialysis
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 00085412917696
- All lots including and manufactured after 24F0085
Distribution
Distributed nationwide across the United States.
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