Events

Recall of Askina Gel 15g

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by B Braun Australia Pty Ltd.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    RC-2018-RN-00364-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2018-05-17
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2018-RN-00364-1
  • Notes / Alerts
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 recall data from the U.S. and Australia.
  • Extra notes in the data
  • Reason
    B.Braun's manufacturing site it has determined that the irradiation dose qualified for sterilisation of specific products was too low. in consequence, the germ reduction through gamma irradiation may not have reached the requested sterility assurance level of 0.000001.To date, there have been no reports of any adverse patient outcome as a result of this issue.
  • Action
    B.Braun is advising customers to identify quarantine and return affected stock as per the instructions given in the Customer letter.

Device

Askina Gel 15g
  • Model / Serial
    Askina Gel 15g Item Code: 001419NAll BatchesARTG Number: 177492(B Braun Australia Pty Ltd - Dressing, hydrogel)Irradiation Dose Qualified for Sterilisation
  • Manufacturer
    B Braun Australia Pty Ltd

Manufacturer

B Braun Australia Pty Ltd