Vascular Solutions issues recall of Guardian II, Guardian II NC valves On February 28, Vascular Solutions Zerusa, a subsidiary of Vascular Solutions (VASC), initiated a nationwide recall of Guardian II and Guardian II NC hemostasis valves used in catheterization procedures. Specific lots of the products have been recalled because they pose a slightly increased risk of air leakage that may lead to an air embolism, which could result in serious injury or death. No injuries have been reported in association with this issue. The U.S. Food and Drug Administration classified this as a Class I recall. FDA defines Class I recalls as "a situation in which there is a reasonable probability that the use of or exposure to the violative product will cause serious adverse health consequences or death."
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