Ivenix infusion kits recalled by FDA due to serious manufacturing defect
The U.S. Food and Drug Administration (FDA) has issued a Class I recall—the most serious type—for a batch of the Ivenix LVP Blood Products Administration Set, distributed by Fresenius Kabi. An error during assembly has resulted in the primary and secondary inlets being reversed, meaning their use could result in a botched transfusion.
According to the company, when assembled correctly, the primary line is labeled with a “P” and the secondary line has a red cap and is labeled “S.” However, due to this error, those labels and components may be reversed or misidentified.
There have been no reported injuries or deaths. However, unfiltered blood could enter a patient’s body if the infusion devices are used. Other potential issues could include flow interruption and underdosing. Associated harms could include severe inflammation, blood clots, low blood pressure, infection and damage to veins.
The dangerous kits are single-use and can be found in hospitals and outpatient clinical settings alike. They must all be identified, isolated and destroyed immediately due to a serious risk of harm to patients. The FDA said patients in critical condition or those with weakened immune systems or other medical complications could die if the products are used.
What is being recalled?
This recall impacts only one lot of products from Fresenius Kabi. Details are as follows:
- Name: Ivenix LVP Blood Products Administration Set Dual-Inlet, Low-Sorbing, Y-Site, Mesh Filter
- Part Number: SET-0014-20
- Unique Device Identifier (UDI): 20811505030034
- Lot Number: FA24K05015
See the image below for details on the manufacturing defect that spurred this recall.
Next Steps
On May 12, Fresenius Kabi said it sent all affected customers a letter alerting them to the issue. Per the company’s instructions, all clinicians are to stop using the affected products immediately.
All recalled infusion kits are to be quarantined to ensure they are not accidentally used. The FDA and Fresenius Kabi ask that all inventory be checked to see whether it is subject to this recall notice, including all products in supply houses.
Clinicians will need to find alternatives until the defective devices are replaced. Fresenius Kabi can be contacted at [email protected] or 1-855-354-6387 to initiate a return.
Additionally, the company and the FDA ask that any adverse events from use of the kits be reported using the contacts above.
The full notice is available here.
Chad is an award-winning writer and editor with over 15 years of experience working in media. He has a decade-long professional background in healthcare, working as a writer and in public relations.