Prismaflex HF1000 set 107140 recalled over a dislodging deaeration chamber
Vantive US Healthcare is recalling 93,576 Prismaflex HF1000 Sets, product code 107140, because the deaeration chamber may dislodge from the Prismaflex Control Unit.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
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 HF1000 SET, product code 107140, 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 93,576 units under UDI/DI 07332414069254, covering all lots including and manufactured after 24G0034CA. 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 HF1000 SET, Product Code 107140; Dialyzer, High Permeability With Or Without Sealed Dialysate System
- Manufacturer
- VANTIVE US HEALTHCARE LLC
- Category
- Medical Device — Dialysis set
- Affected units
- 93,576
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 07332414069254
- All lots including and manufactured after 24G0034CA
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.
See all 8 products in this recall →Related recalls
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