Events

Safety Alert for TEXAS Bronchoscope Tube

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

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
    2018-09-21
  • Event Date Posted
    2018-09-21
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20180921a.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: richard wolf gmbh texas bronchoscope tube medical device manufacturer, richard wolf gmbh, has issued a medical device safety alert concerning its texas bronchoscope tube [product numbers: 825200641, 825200841, 825200842, 825201041, 825201241, 825201441, 825210830, 825211230, and 825211430]. the manufacturer became aware of a potential deficiency of its texas bronchoscope tube product. non-functionally relevant bonding points / cemented areas of the affected products may come loose and therefore lead to an extension of the operating time. generally the affected user discovers such separations of fibers of glue during the visible and the function inspection. they are advised to check their stock and return the affected products to the manufacturer for device correction. according to the manufacturer, the affected products are distributed in hong kong. if you are in possession of the products, please contact your supplier for necessary actions. posted on 21 september 2018.

Device

TEXAS Bronchoscope Tube
  • Model / Serial
  • Product Description
    Medical Device Safety Alert: Medical Device Safety Alert: Richard Wolf GmbH TEXAS Bronchoscope Tube
  • Manufacturer
    Richard Wolf GmbH

Manufacturer

Richard Wolf GmbH