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.
Affected Product
| Product Description | Part Number | UDI-DI | Lot Number |
|---|---|---|---|
| LVP Blood Products Administration Set Dual-Inlet, Low-Sorbing, Y-Site, Mesh Filter | SET-0014-20 | 20811505030034 | FA24K05015 |
What to Do
On May 12, 2025, Fresenius Kabi sent all affected customers a letter recommending the following actions:
- Discontinue the use and distribution of the affected product immediately. Check your inventory and quarantine all affected product at your facility.
- Inform potential product users in your organization of this notification and replace with unaffected product.
Reason for Recall
Fresenius Kabi identified a specific lot of the Ivenix LVP Blood Products Administration Set was incorrectly assembled. Essentially, the primary and secondary inlet lines were reversed during assembly, which may cause an infusion of unfiltered blood to the patient. See Figure 1, Incorrect Assembly, above.
In a properly assembled administration set, the Primary Line has a white cap and should be connected to Primary inlet (“P”). The Secondary line (blood) has a red cap and should be connected to the Secondary inlet (“S”). See Figure 2, Correct Assembly, above.
Use of the affected sets may result in the administration of unfiltered blood or delays in therapy, which—depending on the patient’s condition—could cause the following harms:
- Interruption and underdosing of therapy: The presence of large particulates (>~264 microns) may obstruct the fluid pathway, trigger occlusion alarms, and reduce the volume of blood/blood products delivered.
- Unfiltered blood complications: Particulates in unfiltered blood may cause foreign body reactions and/or lead to granulomas (areas of inflammation), thromboembolism (blood clotting and vessel obstruction), and phlebitis (vein inflammation). In addition to particulates, unfiltered blood may introduce microorganisms into the bloodstream, which could lead to sepsis. Pediatric patients, particularly neonates, have increased risk of serious injury or death from unfiltered blood.
- Hypotension and other complications: Temporary interruption of therapy may lead to hypotension (low blood pressure). Infused blood clots may dissolve, recanalize (reopen a blocked blood vessel), or propagate (grow and extend), increasing the risk of embolism.
- Decreased effectiveness of therapy: Clinical troubleshooting (e.g., identifying the issue and obtaining a replacement set) may delay timely blood administration, particularly critical in urgent care settings.
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 any serious injuries or deaths associated with this issue.
Device Use
The LVP Blood Products Administration Set is a sterile, single use, disposable administration set used with the Ivenix Infusion System to administer red blood cells, platelets, and plasma. The Ivenix Infusion System is used in hospital and outpatient care environments for the controlled administration of fluids through clinically accepted routes of administration: intravenous, intra-arterial, epidural, and subcutaneous to adult, pediatric, and neonate patients.
Contact Information
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 1-855-354-6387.
Unique Device Identifier (UDI)
The unique device identifier (UDI) helps identify individual medical devices sold in the United States from distribution to use. The UDI allows for more accurate reporting, reviewing, and analyzing of adverse event reports so that devices can be identified more quickly, and as a result, problems potentially resolved more quickly.
How do I report a problem?
Health care professionals and consumers may report adverse reactions or quality problems they experienced using these devices to MedWatch: The FDA Safety Information and Adverse Event Reporting Program.
