Events

Recall of Safil Sutures Safil Violet 1 (4) 70cm HR26 Safil Violet 4/0 (1,5) 70cm HR22 Safil Violet Undyed 4/0 (1,5) 70cm, DS24 Safil Violet Undyed 2/0 (3) 70cm HR26 Safil Violet 3/0 (2) 70cm, HR22 Safil Violet 2 (5) 70cm HR 37S Safil Violet 2 (5) 70cm HR37S

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-00737-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2018-06-20
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2018-RN-00737-1
  • 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 has been identified that some of the items in specific batches have damaged packaging which may affect the sterility of the products. no specific monitoring of patients is recommended at this time.To date, there have been no reports of any adverse patient outcome which could be associated with this potential sterility issue.
  • Action
    B. Braun is requesting customers: 1. Identify, quarantine and return affected devices; 2. Do not use affected devices anymore; 3. Patients with affected devices in use should be monitored carefully; 4. Inform the responsible personnel in the relevant facilities; and 5. Confirm receipt of the correspondence as per the instructions given in the Customer Letter.

Device

Safil Sutures Safil Violet 1 (4) 70cm HR26 Safil Violet 4/0 (1,5) 70cm HR22 Safil Violet Undyed 4...
  • Model / Serial
    Safil Sutures Safil Violet 1 (4) 70cm HR26Safil Violet 4/0 (1,5) 70cm HR22Safil Violet Undyed 4/0 (1,5) 70cm, DS24Safil Violet Undyed 2/0 (3) 70cm HR26Safil Violet 3/0 (2) 70cm, HR22Safil Violet 2 (5) 70cm HR 37SSafil Violet 2 (5) 70cm HR37SMultiple Item Codes and Batch NumbersARTG Number: 222738
  • Manufacturer
    B Braun Australia Pty Ltd

Manufacturer

B Braun Australia Pty Ltd