REGULATORY UPDATE: Fresenius Kabi Recalls One Lot of LVP Blood Products Administration Sets

The Food and Drug Administration issued a recall on Tuesday for one lot of Fresenius Kabi’s Ivenix Large-Volume Pump (LVP) Blood Products Administration Set due to incorrect assembly, which could lead to the infusion of unfiltered blood. FDA identified this recall as the most serious type, warning that continued use of the device “may cause serious injury or death.”

The recall affects a dual-inlet, low-sorbing Y-site set with a mesh filter (SET-0014-20) used with the Ivenix Infusion System to deliver red blood cells, platelets and plasma to adult and pediatric patients.

In the affected lot (FA24K05015), the primary and secondary lines were switched during assembly. Use of the affected sets may result in the administration of unfiltered blood or delays in therapy, potentially leading to interruption and underdosing of therapy, unfiltered blood complications (including sepsis), hypotension and decreased therapy effectiveness.

Furthermore, FDA cautioned that clinical outcomes could range from asymptomatic to serious adverse events, especially in vulnerable populations such as neonates, critically ill patients or those undergoing large-volume transfusions. 

Actions for Transfusion Services

Fresenius Kabi notified customers of the recall on May 12 and recommended that they take the following actions:

• Discontinue the use and distribution of affected products immediately. Check inventory and quarantine all affected products at their facility.
• Inform potential product users within their organization of the recall and replace affected sets with unaffected products.

At this time, Fresenius Kabi has not reported any serious injuries or deaths associated with this issue.

Health care professionals should contact Fresenius Kabi at 1-855-354-6387 or via email to report adverse reactions, quality problems or with questions about the recall.