Infusion pumps recalled over downstream occlusion alarms at low flow rates
Fresenius Kabi USA is recalling 15,862 Ivenix Infusion System large volume pumps because downstream occlusion alarms may occur at low flow rates when a check valve is added to the administration set.
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 describes an alarm condition tied to a specific set configuration, with no stated consequence or reported harm.
Plain-English summary
The Ivenix Infusion System (IIS) Large Volume Pump, model LVP-0004, from Fresenius Kabi USA, is being recalled. The device carries UDI-DI 00811505030320.
Downstream occlusion alarms may occur during procedures using low flow infusion rates when a check valve is added to the Ivenix Administration Set.
The recall covers 15,862 units, distributed nationwide in the United States across California, Colorado, Florida, Georgia, Idaho, Illinois, Maryland, Michigan, Minnesota, Mississippi, Nebraska, New Jersey, Nevada, Oklahoma, Oregon, South Carolina, Texas, Utah, Virginia, Washington and Wisconsin. The FDA has classified the action as Class II.
The record describes an alarm condition arising from a specific set configuration and does not state a further consequence or report injuries. Facilities should follow Fresenius Kabi's instructions.
The recalled product
- Product
- Ivenix Infusion System (IIS), Large Volume Pump. Model Number: LVP-0004.
- Manufacturer
- Fresenius Kabi USA, LLC
- Category
- Medical Device — Infusion pump
- Affected units
- 15,862
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 (1)
- Model Number: LVP-0004. UDI-DI: 00811505030320.
Distribution
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