Infusion system software recalled to emphasize instructions in the manual
Fresenius Kabi is recalling 30 units of Ivenix Infusion System LVP software to emphasize the instructions for LVP duration programming set out in the IFU.
What this means for you
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: Scored 1 under the documentation criterion: the action re-emphasizes existing instructions for use, with no device defect or stated consequence.
Plain-English summary
The Ivenix Infusion System (IIS), LVP Software LVP-SW-0005, is being recalled by Fresenius Kabi USA, LLC.
The reason given in the enforcement record is emphasizing instructions for LVP duration programming located in the instructions for use.
The record lists 30 units under product code LVP-SW-0005, UDI 00811505030122, covering software versions 5.10.2 and prior. Distribution was 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, Virginia, Washington and Wisconsin. The FDA has classified the action as Class II.
The record describes a communication that re-emphasizes existing instructions for use, and states no consequence or reported injuries. Facilities should follow Fresenius Kabi's instructions.
The recalled product
- Product
- Ivenix Infusion System (IIS), LVP Software: LVP-SW-0005.
- 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 (3)
- Product Code: LVP-SW-0005
- UDI: 00811505030122
- Software versions 5.10.2 and prior.
Distribution
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