Events

Recall of Contact Detach Infusion Sets ( used in conjunction with a pump to deliver a continuous dose of insulin) Manufactured prior to May 2014

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Australasian Medical & Scientific 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-2015-RN-00703-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2015-07-31
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-00703-1
  • 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
    The manufacturer has identified a slight increase in reported cases of the steel needle breaking during use for infusions sets manufactured prior to may 2014. in a small sub set of these reported cases, this needle breakage has led to hospitalisation for the management of glucose levels and/or treatment for removal of the needle. needle breakage can result in the interruption of insulin delivery and can cause hyperglycaemia, which if left untreated, can result in diabetic ketoacidosis (dka). in addition to the interruption of insulin, a needle remaining in the body might, in rare cases, require surgical removal if the needle does not itself migrate to the surface where it can be removed with a pair of tweezers.
  • Action
    In the event consumers wish to carry on with using the old needle they are reminded to follow the current IFU along with specific additional instructions in the customer letter; OR if they prefer users (including members of the public) can phone AMSL for replacement with unaffected stock. This action has been closed-out on 15/08/2016.

Device

Contact Detach Infusion Sets ( used in conjunction with a pump to deliver a continuous dose of in...
  • Model / Serial
    Contact Detach Infusion Sets ( used in conjunction with a pump to deliver a continuous dose of insulin)Manufactured prior to May 2014Multiple Lot Numbers – see attached listARTG Number: 116234
  • Manufacturer
    Australasian Medical & Scientific Ltd

Manufacturer

Australasian Medical & Scientific Ltd