TOPIC: Excel Lactated Ringers Injection, 1000 mL by B. Braun Medical: Recall - Due to the Presence of Particulate Matter
AUDIENCE: Patient, Health Care Professional, Risk Manager, Pharmacy
ISSUE: B. Braun Medical is recalling one lot of Excel Lactated Ringers Injection, 1000 mL to the hospital/healthcare facility level, due to the presence of particulate matter in solution identified primarily as cellulose cotton fibers, with individual particles also identified as cellulose wood fiber and polystyrene.
Risk Statement: The use of the defective product has a reasonable probability of causing pulmonary emboli (blockage in pulmonary blood vessels), occlusions of other blood vessels (which can lead to tissue death and possible organ damage), and/or phlebitis (inflammation of the walls of veins, which may lead to clotting). Systemically, foreign particles infused intravenously can cause systemic activation of the immune system, organ dysfunction, and hemolysis (breakdown of blood cells).
Product was distributed Nationwide and to Canada to hospitals and healthcare facilities from August 29, 2024, through September 30, 2024.
To date, B. Braun has not received any reports of adverse events related to this recall.
For more information about this recall, click on the red button "Read Recall" below.
BACKGROUND: The product being recalled is used as a source of water and electrolytes for hydration and fluid replacement and may be administered to adult, pediatric and neonatal patients based on clinical need and is packaged in non-PVC, non-DEHP flexible container system.
RECOMMENDATIONS:
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Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product.
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Consumers with questions regarding this recall can contact B. Braun by emailing recalls@bbraunusa.com.
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B. Braun is notifying its distributors and customers by mail and is arranging for return and replacement of all recalled products.
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