FDA labels Vascular's hemostasis valve recall as Class I

03/29/2013 | MassDevice.com (Boston)

A recall initiated by Vascular Solutions involving its Guardian II and Guardian II NC hemostasis valves, which are used to stop blood loss during catheterization procedures, has been labeled as Class I by the FDA. The Minneapolis company recalled the products last month over concerns that air might enter the devices, which could cause an air embolism.

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MassDevice.com (Boston)

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