The United States Food and Drug Administration (FDA) has issued medical device safety alerts concerning Vascu-Guard Peripheral Vascular Patch. The affected devices are identified as follow:-
The manufacturer received customer complaints of difficulty in distinguishing the smooth from rough surface of the Vascu-Guard patch as described in the instructions for use. This is due to a deviation in the surface texture of the vascular patch in a new packaging configuration.
The manufacturer is recalling above product codes of its Vascu-Guard Peripheral Vascular Patch. Users can still order this product presented in a plastic jar filled with sterile water and 1% Propylene Oxide, such configuration is unaffected by this recall.
For details, please refer to the FDA websites:
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm449592.htmhttp://www.fda.gov/Safety/Recalls/ucm449477.htm
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 04 June 2015