Prismaflex M150 sets recalled over a deaeration chamber that may dislodge
Vantive US Healthcare is recalling 137,576 units of the PRISMAFLEX M150 SET 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 M150 SET, product code 109990, 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 137,576 units under UDI/DI 07332414090005, covering all lots including and manufactured after 24F0100CA. 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 M150 SET, Product Code 109990; Dialyzer, High Permeability With Or Without Sealed Dialysate System
- Manufacturer
- VANTIVE US HEALTHCARE LLC
- Category
- Medical Device — Dialysis set
- Affected units
- 137,576
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.
Part of a larger recall action
This product is one of 8 recalled by VANTIVE US HEALTHCARE LLC under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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