Events

Recall of Sterile Single Use Minor Surgery Bipolar Cable, IEC-BC (Used for connecting the bipolar handpieces to the RF generator for electrosurgical procedures)

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Cynosure 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-01267-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2016-09-28
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-01267-1
  • 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
    Cynosure has identified an error in the expiration date on the label of the minor surgery bipolar cable pouch. the expiration date on the individual pouches that are provided in the 5 pack boxes does not match the expiration date on the box. the expiration date on the box is correct with a date of 2018-02, but the label on the individual pouches has a date of 2021-02. if the cable is used after that date, sterility may be compromised.
  • Action
    Customers are advised to return any affected cables that they hold. Cynosure will be replacing affected cables upon receipt of the returned cables. This action has been closed-out on 12/05/2017.

Device

Sterile Single Use Minor Surgery Bipolar Cable, IEC-BC (Used for connecting the bipolar handpiece...
  • Model / Serial
    Sterile Single Use Minor Surgery Bipolar Cable, IEC-BC (Used for connecting the bipolar handpieces to the RF generator for electrosurgical procedures)Affected Lot numbers on package: 50858, 50382, 48543, 50704Affected Lot numbers on BC: 45572,48543 ARTG Number: 274615
  • Manufacturer
    Cynosure Pty Ltd

Manufacturer

Cynosure Pty Ltd