Events

Safety Alert for vv28f 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
    2017-09-14
  • Event Date Posted
    2017-09-14
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20170914.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 vv28f reinforced dual lumen ecmo catheters the united states food and drug administration (fda) has issued a medical device safety alert concerning vv28f reinforced dual lumen extracorporeal membrane oxygenation (ecmo) catheters [catalogue number vv28f; lot numbers: n18487 and n18487-1], manufactured by origen biomedical. the manufacturer initiated a recall for these two lots of vv28f reinforced dual lumen ecmo catheters. the affected vv28f reinforced dual lumen ecmo catheters have been found to have the potential for a separation of the clear extension tube from the hub that it is inserted in, which potentially could result in required intervention to prevent permanent impairment/damage. the manufacturer is aware of two product failures and has received two complaints associated with the problem. a recurrence of this event could result in serious patient injury. the manufacturer is arranging for return of all recalled product. for details, please refer to the fda websites: https://www.Fda.Gov/safety/medwatch/safetyinformation/safetyalertsforhumanmedicalproducts/ucm575937.Htm https://www.Fda.Gov/safety/recalls/ucm575736.Htm if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 14 september 2017.

Device

vv28f reinforced dual lumen ecmo catheters

Manufacturer

OriGen Biomedical