Ivenix Infusion System recall
Ivenix Infusion System (IIS), Large Volume Pump (LVP) Software: 5.0.0 and 5.0.1 Part Number: LVP-SW-0004. Indicated for use in a hospital and in…
Why was Ivenix Infusion System recalled?
Start-up time for the flow rate range greater than 50 ml/hr, and less than 200 ml/hr may exceed the specified 6 minutes, depending on the characteristics of air bubble entrapment within the Intermediate Pumping Chamber (IPC) of the administration set
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA 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): 00811505030122 Software Version: 5.0.0 and 5.0.1
- Product
- Ivenix Infusion System (IIS), Large Volume Pump (LVP) Software: 5.0.0 and 5.0.1 Part Number: LVP-SW-0004. Indicated for use in a hospital and in…
- Recalling firm
- Fresenius Kabi USA, LLC
- Quantity
- 1344 pumps
- Distribution
- US Nationwide distribution in the states of NJ, WI.
- Recall date
- October 4, 2023
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)