Vascular Solutions Inc., Guardian II and Guardian II NC Hemostasis Valves: Class I Recall
MedSun: Newsletter #83, April 2013

FDA MedWatch Safety Alert

FDA notified healthcare professionals of a Class I recall of the Vascular Solutions Inc., Guardian II and Guardian II NC Hemostasis Valves, Model Numbers 8210, 8211, 8215, and 8216. The firm is recalling the product due to a risk that air may be introduced into the device which may lead to an air embolism.

Additional Information:

FDA MedWatch Safety Alert. Vascular Solutions Inc., Guardian II and Guardian II NC Hemostasis Valves: Class I Recall. March 27, 2013.
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm345520.htm


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