Events

Safety Alert for GoPump and GOBlock Rapid Recovery System kits

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

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
    2013-05-20
  • Event Date Posted
    2013-05-20
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20130520b.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: symbios medical products gopump and goblock rapid recovery system kits the united states food and drug administration (fda) has posted a press release issued by symbios medical products concerning their gopump and goblock rapid recovery system kits. according to the press release, the manufacturer initiated a voluntary recall of all gopump rapid recovery system kits and goblock kits manufactured with flow control components assembled prior to jul 2012. products subject to this recall were distributed between 1 apr 2011 and 30 apr 2013. these products have been found to potentially cause excessively high flow rates, which presents a risk of patient toxicity and serious injury (e.G., seizure, dysrhythmia, death) due to the rapid influx of medication particularly in patients with low body mass or advanced age. to date, there have been 5 complaints received, two of which involved serious consequences. there have been no patient deaths reported. the root cause is understood and processes have been put in place to address the issue. for details, please visit the following fda website: http://www.Fda.Gov/safety/recalls/ucm352627.Htm if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 20 may 2013.

Device

GoPump and GOBlock Rapid Recovery System kits

Manufacturer

N/A
  • Source
    DH