Ivenix infusion pump cassette loading levers may break
The Large Volume Pump of the Ivenix Infusion System is being recalled because of the potential for the Cassette Loading Lever to break. 18,444 installed bases are affected.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II recall where a component that loads the infusion cassette may break, a risk of harm with no injuries reported in the source.
Plain-English summary
The Large Volume Pump (LVP) of the Ivenix Infusion System, model number LVP-0004, UDI-DI 00811505030320, is being recalled. The action covers 18,444 installed bases.
The stated reason is the potential for the Cassette Loading Lever to break. The lever is used to seat the infusion cassette in the pump. The FDA classified the action as Class II.
Distribution was nationwide in the United States, including California, Colorado, Florida, Georgia, Idaho, Illinois, Massachusetts, Maryland and Maine. The pumps are installed in healthcare facilities rather than sold to consumers.
Facilities should identify affected units using the model number and UDI-DI above and follow the instructions issued by the manufacturer.
The recalled product
- Product
- The Large Volume Pump (LVP) of the Ivenix Infusion System (IIS). Model Number: LVP-0004.
- Manufacturer
- Fresenius Kabi USA, LLC
- Category
- Medical Device — Infusion pump
- Affected units
- 18,444
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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