Events

Safety Alert for Hand Control 12FR Suction Coagulator with 10 foot Cord and Holster, Sterile, Disposable

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

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
    2014-03-26
  • Event Date Posted
    2014-03-26
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20140326b.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: megadyne hand control 12fr suction coagulator with 10 foot cord and holster, sterile, disposable health canada has issued a medical device safety alert concerning hand control 12fr suction coagulator with 10 foot cord and holster, sterile, disposable with catalogue number 0043-25 and lot number 132405, manufactured by megadyne medical products inc. a specific lot of suction coagulators may malfunction by remaining in the on position (independent and continuous activation until disconnected from electrosurgical generator). the resulting malfunction could result in serious patient injury. for details, please visit the following health canada website:http://www.Healthycanadians.Gc.Ca/recall-alert-rappel-avis/hc-sc/2014/38623r-eng.Php if you are in possession of the affected product, please contact your supplier for necessary actions. posted on 26 march 2014.

Device

Hand Control 12FR Suction Coagulator with 10 foot Cord and Holster, Sterile, Disposable
  • Model / Serial
  • Product Description
    Medical Device Safety Alert: Megadyne Hand Control 12FR Suction Coagulator with 10 foot Cord and Holster, Sterile, Disposable
  • Manufacturer
    Megadyne Medical Products Inc

Manufacturer

Megadyne Medical Products Inc