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FDA Medwatch Alert: Baxter IV Solutions: Recall - Potential Presence of Particulate Matter

Posted 5 Jan 2016 by

Includes: 0.9% Sodium Chloride Injection, USP, 250 mL VIAFLEX Plastic Container 70% Dextrose Injection (2000 mL) USP ISSUE: Baxter International Inc. announced a voluntarily recall of two lots of intravenous (IV) solutions to the hospital/end user level due to the potential presence of particulate matter. The particulate matter in each case was determined to be an insect and was identified as a result of a customer complaint. The lots being recalled were distributed to customers and distributors in the United States between June 6, 2015 and December 16, 2015. See the Press Release for affected lot numbers. Injecting a product containing particulate matter, in the absence of in-line filtration, may result in blockage of blood vessels, which can result in stroke, heart attack or damage to other organs such as the kidney or liver. There is also the possibility of allergic reactions, ... Read more

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