Guardian II Hemostasis Valve Recall [US]

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US/Silver Spring: FDA Logo BlueVascular Solutions, Inc. recalls certain batch/lots of Guardian II Hemostasis Valves due to increased risk of air leakage that may lead to an air embolism, injury and death, all serious health hazards. FDA:

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Additional information:
The US Food and Drug Administration (“FDA”) reports the following Medical Devices are subject to this recall:

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