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:-

• Model numbers:
  • 1504026 VASCU-GUARD TS 1x6cm
  • 1504028 VASCU-GUARD TS 0.8x8cm
  • 1504030 VASCU-GUARD TS 1x10cm
  • 1504032 VASCU-GUARD TS 2x9cm

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