Events

Safety Alert for Askina Gel and Calgitrol Paste

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

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
    2018-05-02
  • Event Date Posted
    2018-05-02
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20180502a.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: b. braun hospicare ltd askina gel and calgitrol paste medical device manufacturer, b. braun hospicare ltd., has issued a medical device safety alert concerning its askina gel and calgitrol paste [article number: 14291, 001419n, 001419nru, 001419s, 001419sbr, 001419ses, 001419sescp, 001419sf, 001419sfr, 001419sru, 6241001, 6241505, 6241505f, 6241510, 6242501, 6242501fr, 6245001]. in the manufacturing site, it was determined that the irradiation dose qualified for sterilization of the above mentioned products was too low. in consequence, the germ reduction through gamma irradiation may not have reached the requested sterility assurance level of 10-6. the effect cannot be limited to specific batches. according to the manufacturer, there was no market feedback on any adverse patient outcome which could be associated to the above described observation. however, the manufacturer decided to recall the affected products from the market as a preventive measure. the affected users are asked to take the following actions: identify and quarantine the affected devices; do not use affected devices anymore; patients with affected devices in use should be monitored carefully. if clinically uneventful, an exchange of the product is not indicated. 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 2 may2018.

Device

Askina Gel and Calgitrol Paste
  • Model / Serial
  • Product Description
    Medical Device Safety Alert: B. Braun Hospicare Ltd Askina Gel and Calgitrol Paste
  • Manufacturer
    B

Manufacturer

B