Events

Safety Alert for Radius Loop Electrode Box of 5

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

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
    2014-10-31
  • Event Date Posted
    2014-10-31
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20141031.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: coopersurgical radius loop electrode box of 5 medical device manufacturer, coopersurgical, has issued a field safety notice concerning its radius loop electrode box of 5. the affected part number is r2010 and lot number is 159621. the product may have been packaged with an incorrectly labeled package type (radius loop electrode p/n r1010). the affected product is a single-use sterile disposable device. the product package contains 5 individually sealed pouches consisting of clear plastic front and a tyvek lid back. the device lot number and expiration date is located on the tyvek lid as well as on the side of the external packaging. according to the manufacturer’s health hazard evaluation report, the potential hazard situation associated with the nonconformance is minimal and no adverse events or injuries have been reported to date in connection with the use of the affected product. the manufacturer advises customers to return the affected products to them and product replacement can be arranged. according to the manufacturer, the affected products were distributed in hong kong. if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 31 october 2014.

Device

Radius Loop Electrode Box of 5
  • Model / Serial
  • Product Description
    Medical Device Safety Alert: CooperSurgical Radius Loop Electrode Box of 5
  • Manufacturer
    CooperSurgical

Manufacturer

CooperSurgical