Events

Safety Alert for breathing system components

According to Department of Health, this safety alert involved a device in Hong Kong that was produced by Unomedical-A ConvaTec Company should not be used.

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
    2011-10-11
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20111011.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
    Mhra field safety notice: breathing system components the uk medicines and healthcare products regulatory agency (mhra) issued a field safety notice to alert healthcare providers and customers that some products manufactured by unomedical-a convatec company should not be used. according to the manufacturer, there was a logistical error that has occurred in a small number of their medical devices. these devices have been shipped to customers after their intended shelf life has passed and should not be used. the involved devices are: ‧ high vac 600ml bottle with drain and trocar, connecting tube & nrv, ch18 ‧ high vac 600ml bottle with drain and trocar, connecting tube and nrv, ch14 ‧ tracheostomy mask, paediatric ‧ up-mist nebulizer, with "t piece", mouth piece and 2.1m oxygen tubing, adult ‧ ecoclip-3 three of the lots sold past expiry are sterile products. since it cannot be certain that the devices will continue to remain both safe and efficacious in accordance with their intended use, the manufacturer is recalling all the affected devices. the affected devices can be identified by product lot number in conjunction with the product reference number. the lot number and reference number can be found on the device label which is located on both the primary packaging as well as the shipping carton. the affected products are identified as below: product description sterile product? lot number nhs supply chain catalogue codes 26057018 high vac 600ml bottle with drain and trocar, connecting tube & nrv, ch18 yes 040424 n/a 041116 26057014 high vac 600ml bottle with drain and trocar, connecting tube & nrv, ch14 yes 041110 fwx119 246mm tracheostomy mask, paediatric no 03-36 n/a 952mm up-mist nebulizer, with "t piece" mouth piece and 2.1m oxygen tubing, adult no 05-49 fde394 1110130970 ecoclip-3 (this device has now been discontinued) no 4777/4 n/a for details, please refer to the following mhra website: http://www.Mhra.Gov.Uk/safetyinformation/safetywarningsalertsandrecalls/fieldsafetynotices/ index.Htm if you are in possession of the affected products, please stop using them and contact your supplier for necessary actions.

Device

breathing system components

Manufacturer

Unomedical-A ConvaTec Company should not be used