Events

Recall of ROTH NET POLYP

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by UNITED STATES ENDOSCOPY GROUP INC. ALSO TRADING AS US ENDOSCOPY.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    26650
  • Event Risk Class
    III
  • Event Initiated Date
    2016-12-23
  • Event Country
    Canada
  • Event Source
    HC
  • Notes / Alerts
    Canadian data is current through March 2018. All of the data comes from Health Canada, 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 recall data from the U.S. and Canada.
  • Extra notes in the data
  • Reason
    Us endoscopy has identified that the expiration date is incorrect on the outer packing label for roth net polyp retrieval (00711151 lot 1613898). the expiration date printed is earlier than the actual expiration date. the performance of the product is not impacted. it is important to note that all individually labeled roth net devices contained within the outer shipping package reference the correct expiration date.

Device

ROTH NET POLYP

Manufacturer

UNITED STATES ENDOSCOPY GROUP INC. ALSO TRADING AS US ENDOSCOPY
  • Manufacturer Address
    MENTOR
  • Manufacturer Parent Company (2017)
    Steris Plc
  • Source
    HC