TOPIC: OPTIRAY Imaging Bulk Package - 350, 500 mL, Vial by Liebel-Flarsheim Company: Recall - Due to Presence of Particulate Matter
AUDIENCE: Patient, Health Care Professional, Risk Manager, Radiology, Hematology, Cardiology
ISSUE: Liebel-Flarsheim Company is recalling one lot of OPTIRAY Imaging Bulk Package (IBP) 350, 500 mL in vial, (Ioversol injection 74% 350 mg iodine/ml) for intra-arterial or intra-venous use to the user level (hospitals, imaging centers, healthcare facilities and clinics, and other potential users of the product) due to the presence of particulate matter comprising polyethylene and other plastic materials, stainless steel and glass.
Risk Statement: The administration of an injectable product containing particulate matter may result in local irritation or swelling. More serious risks in compromised patients include serious life-threatening events such as blockage of blood vessels and blood clots.
The affected OPTIRAY 350 IBP 500 mL was distributed in the United States and Mexico to distributors and end users (such as hospitals, imaging centers, healthcare facilities and clinics).
To date, Liebel-Flarsheim Company has not received any reports of adverse events related to this issue.
For more information about this recall, click on the red button "Read Recall" below.
BACKGROUND: The product being recalled is used as a radiographic contrast agent.
RECOMMENDATIONS:
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Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to using this drug product.
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Consumers with questions regarding this recall can contact Liebel-Flarsheim Company to information posted on the recall.
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Liebel-Flarsheim Company is notifying its distributors and customers by email and is arranging for return and replacement of all recalled products.
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Distributors, hospitals, healthcare facilities and clinics, and other healthcare providers that have the recalled product should immediately stop use and/or further distribution, quarantine all affected product inventory, and follow the instructions in the customer recall notification for arranging return of the affected lot to Liebel-Flarsheim Company.
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