Events

Recall of BD Epilor Plastic BD Luer-Lok Loss of Resistance (LOR) Syringe (7mL) (Used in conjunction with an epidural needle for identifying epidural space)

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Becton Dickinson 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-2013-RN-00922-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2013-09-06
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-00922-1
  • 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
    Bd has received complaints relating to difficulty in moving the plunger rod or the plunger rod sticking. this has the potential to prevent the anaesthetist from correctly detecting the loss of resistance upon entering the epidural space.
  • Action
    Prior to using each syringe, it is recommended that anaesthetists ensure that there is no difficulty in moving the plunger rod and that the plunger rod does not stick. Any LOR Syringe that shows inappropriate resistance should be discarded; the procedure can then be continued by using another LOR Syringe that does not show resistance.

Device

BD Epilor Plastic BD Luer-Lok Loss of Resistance (LOR) Syringe (7mL) (Used in conjunction with an...
  • Model / Serial
    BD Epilor Plastic BD Luer-Lok Loss of Resistance (LOR) Syringe (7mL) (Used in conjunction with an epidural needle for identifying epidural space)Reference Number: 405291Lot Numbers: 0039440, 0154661, 0174905, 0252565, 1012200, 1124755, 1213029, 1312116, 1320204, 2286395, 2303141, 2334338, 2334339, 8277525, 8357843, 9093622 and 9149990ARTG Number: 120174
  • Manufacturer
    Becton Dickinson Pty Ltd

Manufacturer

Becton Dickinson Pty Ltd