Events

Recall of Rocket IPC Drainage Bottle (A collection device used to collect fluid or air from the pleural cavity)

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Rocket Medical 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-2014-RN-01151-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2014-11-14
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-01151-1
  • 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
    Rocket medical is notifying customers the blue connector tube may not open once the white clip is removed due to a manufacturing irregularity. if this occurs the vacuum contained in the bottle will not be applied to the patient, therefore no fluid can be drained. if left, the connector tube will still open with a delay of up to 5-6 minutes.
  • Action
    Rocket Medical is advising customers to open the tube by gently manipulating the tube forwards and backwards when the white clip has been opened. This action has been closed-out on 01/03/2016.

Device

Rocket IPC Drainage Bottle (A collection device used to collect fluid or air from the pleural cav...
  • Model / Serial
    Rocket IPC Drainage Bottle (A collection device used to collect fluid or air from the pleural cavity)Product Codes: R54400, R54400-00-PP, R54410, R51400, R51400-00-PP, R51410ARTG Number: 145658
  • Manufacturer
    Rocket Medical Pty Ltd

Manufacturer

Rocket Medical Pty Ltd