Events

Safety Alert for Adelante Breezeway 8F and 10F

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

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
    2016-10-13
  • Event Date Posted
    2016-10-13
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20161013b.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: oscor adelante breezeway 8f and 10f medical device manufacturer, oscor incorporation, has issued a medical device safety alert concerning its adelante breezeway 8f and 10f [model number: ab081041; lot number (date of manufacture): c1-12312 (19 jan 2016), or-04686 (17 jul 2015)]. the manufacturer has been made aware of a complaint where a fragment of the sheath inner liner came off during the insertion of the dilator in the preparation of the sheath prior to use. according to the manufacturer, the reported failure did not cause patient injury; however, the risk for possible injury is a concern if the sheath is not properly flushed and tested with dilator prior to use. the users are advised to take the following actions: immediately check their inventory to confirm that they do or do not have units from these lot(s) in their possession. identify and set aside any unit from the identified lot in a manner that ensures the affected product will not be used. check all storage and usage. according to the local supplier, the affected products are distributed in hong kong. if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 13 october 2016.

Device

Adelante Breezeway 8F and 10F
  • Model / Serial
  • Product Description
    Medical Device Safety Alert: Oscor Adelante Breezeway 8F and 10F
  • Manufacturer
    Oscor Incorporation

Manufacturer

Oscor Incorporation