Events

Safety Alert for Vascu-Guard Peripheral Vascular Patch

According to Department of Health, this safety alert involved a device in Hong Kong that was produced by Baxter.

What is this?

Alerts provide important information and recommendations about products. Even though an alert has been issued, it does not necessarily mean a product is considered to be unsafe. Safety Alerts, addressed to health workers and users, may include recalls. They can be written by manufacturers, but also by health officials.

Learn more about the data here
  • Type of Event
    Safety alert
  • Date
    2015-06-04
  • Event Date Posted
    2015-06-04
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20150604a.html
  • Notes / Alerts
    Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Hong Kong.
  • Extra notes in the data
    Medical Device Safety Alert
  • Reason
    Medical device safety alert: baxter vascu-guard peripheral vascular patch 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.Htm http://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.

Device

Vascu-Guard Peripheral Vascular Patch
  • Model / Serial
  • Product Classification
    Cardiovascular Devices
  • Product Description
    Medical Device Safety Alert: Baxter Vascu-Guard Peripheral Vascular Patch
  • Manufacturer
    Baxter

Manufacturer

Baxter