Events

Recall of Safil Quick (synthetic absorbable sterile surgical suture)

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-2016-RN-00855-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2016-07-01
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-00855-1
  • 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
    A defect has been detected by the manufacturer, which is that the needle detaches very easily during surgery, resulting in the suture having to be replaced and the wound sutured a second time.
  • Action
    B Braun is advising users to inspect stocks and quarantine all units. B Braun will arrange for stock to be recovered and will issue a credit note. This action has been closed-out on 28/02/2018.

Device

Safil Quick (synthetic absorbable sterile surgical suture)
  • Model / Serial
    Safil Quick (synthetic absorbable sterile surgical suture)Article Code: C1046619 Batch Number: 115441 ARTG Number: 220500
  • Manufacturer
    B Braun Australia Pty Ltd

Manufacturer

B Braun Australia Pty Ltd