Events

Recall of Sorbsan Calcium Alignate Dressings (Flat, Ribbon, Packing, Plus and Border) and Sorbsan Silver Calcium Alignate Dressing (Flat)

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Bosco Medical Australia.

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-00727-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2016-06-01
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-00727-1
  • 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
    Bosco medical australia has become aware of an issue related to the application of an incorrect expiry date to a number of sorbsan dressings. product has been labelled incorrectly with a 5 year expiry date instead of a 3 year expiry date. product effectiveness may be impacted if used past a three year shelf life, and may result in the need to change the dressing more often.
  • Action
    Bosco Medical is advising customers to inspect stock and quarantine any remaining units of affected stock, for return to Bosco.

Device

Sorbsan Calcium Alignate Dressings (Flat, Ribbon, Packing, Plus and Border) and Sorbsan Silver Ca...
  • Model / Serial
    Sorbsan Calcium Alignate Dressings (Flat, Ribbon, Packing, Plus and Border) and Sorbsan Silver Calcium Alignate Dressing (Flat)Product Codes: 1400, 1410, 1411, 1412, 1415, 1420SA, 1421, 1421C, 1423, 1423C, 1425Multiple Lot Numbers affectedARTG Number: 168684
  • Manufacturer
    Bosco Medical Australia

Manufacturer

Bosco Medical Australia