Events

Safety Alert for vv13f reinforced dual lumen ecmo catheters

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

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
    2015-04-17
  • Event Date Posted
    2015-04-17
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20150417b.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: origen biomedical vv13f reinforced dual lumen ecmo catheters the united states food and drug administration (fda) has issued a medical device safety alert concerning vv13f reinforced dual lumen ecmo catheters, manufactured by origen biomedical. the manufacturer initiated a recall for one lot (lot n18549, expiration 09/2018) of 51 vv13f reinforced dual lumen ecmo catheters in the united states. these vv13f reinforced dual lumen ecmo catheters have been found to have the potential for a separation of the clear extension tube from the hub in which it is inserted, which potentially could result in required intervention to prevent permanent impairment/damage. affected users who have lot n18549 of vv13f reinforced dual lumen ecmo catheters should return any product that they currently have to origen biomedical. for details, please refer to the fda website: http://www.Fda.Gov/safety/medwatch/safetyinformation/safetyalertsforhumanmedicalproducts/ucm443025.Htm http://www.Fda.Gov/safety/recalls/ucm443009.Htm if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 17 april 2015.

Device

vv13f reinforced dual lumen ecmo catheters

Manufacturer

OriGen Biomedical