Ivenix Infusion System recall
Ivenix Infusion System (IIS), LVP Software; LVP-SW-0004 version 5.2.0
Why was Ivenix Infusion System recalled?
The display screen may become frozen and unresponsive to user input, triggering an alarm that is evidenced by a buzzer sound and flashing red LEDs as a secondary notification. However, as the screen goes blank it does not indicate an alarm condition or respond. This issue leads to temporary cessation of flow of a medication or fluid, requiring immediate intervention by the clinician.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
UDI-DI: 00811505030122 version 5.2.0
- Product
- Ivenix Infusion System (IIS), LVP Software; LVP-SW-0004 version 5.2.0
- Recalling firm
- Fresenius Kabi USA, LLC
- Quantity
- 4 instances
- Distribution
- Domestic distribution to NJ and WI.
- Recall date
- October 12, 2022
- Classification
- Class I
- Status
- Terminated
- Agency
- FDA (device)