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Vascular Solutions Issues Recall on Guardian® II and Guardian II NC Hemostasis Valves Due to Risk of Air Embolism

Filed March 18th, 2013 Joshua Sophy

A nationwide recall has been issued on medical devices used during catheterization procedures because use of them could result in serious injury or death to patients.

According to a notice from Vascular Solutions Zerusa Ltd., the recall action includes its Guardian® II and Guardian II NC hemostasis valves. These devices could leak air during their use and potentially cause an air embolism to develop, a life-threatening situation for any patient who receives a treatment utilizing these devices.

The U.S. Food and Drug Administration (FDA) has classified this recall action as Class I. When the FDA deems a company’s recall action as Class I, it indicates that the agency believes using these medical devices poses a serious and life-threatening risk to patients, according to the release from Vascular Solutions.

No injuries have been reported to Vascular Solutions prior to or since it initiated a recall on these devices in late-February. The company notified its customers of the specific Lots included in the recall notice and provided them with instructions for returning them through an Urgent Medical Device Recall notice issued on Feb. 28, 2013. At the time of that recall, Vascular Solutions told its customers who receive these Guardian® II and Guardian II NC hemostasis valves that they should remove them from their inventories, according to Vascular Solutions’ press release announcing the recall.

The recall is specific to Guardian® II and Guardian II NC hemostasis valves manufactured and distributed from Vascular Solutions between February 2012 and February 2013. The following Model numbers are included in the recall action: 8210, 8211, 8215, 8216, 8241, 8242, 8244, 8272, and 8274, according to the information provided by Vascular Solutions.

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