Particles and leaking IV bag results in product recall

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FDA report “Baxter International Inc. announced today it is voluntarily recalling one lot of intravenous (IV) solution to the hospital/user level due to the potential for leaking containers, particulate matter and missing port protectors. Baxter was made aware of these issues through customer complaints. There have been no adverse events associated with this lot reported to Baxter to date.

Leaking containers, particulate matter and missing port protectors could result in contamination of the solution. If not detected, this could lead to a bloodstream infection or other serious adverse health consequences. 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, local irritation and inflammation in tissues and organs.”

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