B. Braun Medical is recalling two lots of Lactated Ringers Injection USP, 1000 mL and 0.9% Sodium Chloride Injection USP, 1000 mL to the hospital level due to the presence of particulate matter inside the container.
B. Braun has identified through complaints the potential for the product to contain particulate matter in solution. To date there have been no reports of serious injury, death or other adverse events associated with this issue. If the particulate matter is observed before use, a minor delay could occur while obtaining a replacement product. If the particulate matter is loose and the container is used on a patient, there is a potential for the particulate to be infused into the circulatory system. This could lead to patient harm that may require additional medical intervention and/or lead to permanent impairment or death.
The product being recalled 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).
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