Infusion pump software recalled over anomalies that could cause serious harm
Fresenius Kabi USA is recalling Ivenix Infusion System LVP software versions 5.10.1 and earlier, which the firm states contain anomalies with the potential to cause serious patient harm or death.
The agency’s classification
FDA (Devices): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
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 5/5 (Critical).
Highest-severity recall. The hazard can cause serious injury or death. Stop using the product now and follow the agency's instructions.
Our severity reasoning: Scored 5 because the FDA has classified this action as Class I, which the rubric maps directly to Critical.
Plain-English summary
The Ivenix Infusion System (IIS) LVP Software, LVP-SW-0005, software for the controlled administration of fluids to patients, is being recalled by Fresenius Kabi USA, LLC.
Software version 5.10.1 and earlier contain anomalies that the firm states have the potential to cause serious patient harm or death.
The record lists 30 units, covering software versions 5.10.1 and prior under UDI 00811505030122. Domestic distribution covered California, Colorado, Florida, Georgia, Idaho, Illinois, Maryland, Michigan, Minnesota, Mississippi, Nebraska, New Jersey, Nevada, Oklahoma, Oregon, South Carolina, Texas, Virginia, Washington and Wisconsin. The FDA has classified the action as Class I, its most serious category.
Facilities should follow Fresenius Kabi's instructions immediately.
The recalled product
- Product
- Ivenix Infusion System (IIS), LVP Software LVP-SW-0005. Software for the controlled administration of fluids to patients.
- Manufacturer
- Fresenius Kabi USA, LLC
- Category
- Medical Device — Infusion pump
- Affected units
- 30
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)
- Software Versions 5.10.1 and prior
- UDI: 00811505030122.
Distribution
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