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Blood Products Administration Set Recall: Fresenius Kabi Removes Large Volume Pump Blood Products Administration Sets due to Incorrect Assembly
The FDA is aware that Fresenius Kabi has identified a specific lot of the Ivenix LVP Blood Products Administration Set was incorrectly assembled.
Clinical outcomes can vary from asymptomatic to serious adverse events, especially in vulnerable populations such as neonates, critically ill patients, or those undergoing large-volume transfusions. Short-term and long-term complications will vary depending on the patient population, the underlying condition, health status of the patient, and the treatment regimen.
At this time, Fresenius Kabi has not reported serious injuries or deaths associated with this issue.
This recall involves removing certain devices from where they are used or sold. The FDA has identified this recall as the most serious type. This device may cause serious injury or death if you continue to use it.
Questions?
Customers in the U.S. with adverse reactions, quality problems, or questions about this recall should contact Fresenius Kabi at Ivenix_support@fresenius-kabi.com or 855-354-6387.
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