Events

Safety Alert for Disposable Resuscitators

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

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
    2012-05-15
  • Event Date Posted
    2012-05-15
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20120515.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: bomimed. disposable resuscitators the health canada (hc) posted a recall notice concerning disposable resuscitators manufactured by bomimed, inc. according to the manufacturer, during in-house testing, it was discovered that if the maks were squeezed too hard, the plastic shell could crack, resulting in the inability of the mask to ventilate. for details, please refer to hc website: http://www.Hc-sc.Gc.Ca/dhp-mps/compli-conform/recall-retrait/_list/rec-ret_md-im_date_apr-june_2012-eng.Php if you are in possession of the product, please contact your supplier for necessary actions. posted 15 may 2012.

Device

Disposable Resuscitators
  • Model / Serial
  • Product Description
    Medical Device Safety Alert: BOMImed. Disposable Resuscitators
  • Manufacturer
    BOMImed

Manufacturer

BOMImed