Events

Recall of Plastic Cannula – 11 gauge

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by CareFusion Australia 316 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-2017-RN-01163-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2017-09-06
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-01163-1
  • 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
    Becton dickinson (bd) has identified punctures in the blister packaging detected during the packaging process for specific lots of plastic cannula – 11 gauge.A breach in the sterile barrier has the potential to render the device non-sterile. it is possible end users may not detect the pin holes, thus utilising impacted product clinically. this could result in harm to patients especially when immunocompromised.In association with this recall, bd has decided to discontinue catalogue number: 9391-0200.To date, bd is not aware of any report of injury attributed to this defect in australia.
  • Action
    1. Users are to discontinue use of and segregate the identified Lot Numbers of Catalogue Number 9391-0200 (Plastic cannula – 11 gauge). 2. Complete the supplied Customer Acknowledgement Form to confirm receipt of this notification. 3. Becton Dickinson is requesting that any impacted inventory be returned. 4. Becton Dickinson will arrange for the pick-up of your affected stock and issue a credit to your account.

Device

Plastic Cannula – 11 gauge
  • Model / Serial
    Plastic Cannula – 11 gauge Catalogue Number: 9391-0200Lot Numbers: 1470303001, 1470304601, 1470306301, 1470311301, 1470314801, 1570314802, 1570317701, 1570317702, 1570317704, 1570322001ARTG Number: 189737
  • Manufacturer
    CareFusion Australia 316 Pty Ltd

Manufacturer

CareFusion Australia 316 Pty Ltd