Cardiovascular imaging contrast agent recalled due to risk of contamination
Liebel-Flarsheim, an Ohio-based subsidiary of Guerbet, has recalled a single lot of one of its iodinated contrast agents due to the presence of particulate matter that contains polyethylene, stainless steel, glass and other potentially harmful materials.
Liebel-Flarsheim first announced the recall on Friday, July 31, and the U.S. Food and Drug Administration (FDA) shared details with the public on Tuesday, Aug. 4.
Key details about the recalled contrast agent
This recall covers one lot, 25ZF3670, of Liebel-Flarsheim’s Optiray 350 Imaging Bulk Package. This is an injectable contrast agent that contains ioversol. Specialists use it to visualize blood vessels during peripheral arteriography, coronary arteriography and left ventriculography tests. The vials, distributed to hospitals, clinics and imaging centers throughout the United States and Mexico, expire in May 2027.
Image courtesy of the FDA.
According to Liebel-Flarsheim, patients treated with this agent may face certain risks. Customers should immediately stop using these vials and work toward returning them to the manufacturer.
“The administration of an injectable product containing particulate matter may result in local irritation or swelling,” the company warned. “More serious risks in compromised patients include serious life-threatening events such as blockage of blood vessels and blood clots.”
Liebel-Flarsheim has not received reports of any adverse events associated with this issue.
Click here to read the full advisory from the FDA.
Michael has more than 19 years of experience as a professional writer and editor. He has written at length about cardiology, radiology, artificial intelligence and other key healthcare topics.