Events

Recall of BD Vacutainer Eclipse Signal Blood Collection Needle with Integrated Holder 21G & 22G.21G

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-2015-RN-00728-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2015-08-11
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-00728-1
  • 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 become aware that some lots of the bd vacutainer eclipse signal blood collection needle with integrated holder (catalogue numbers 368835 and 368836) have the potential for the integrated holder to become detached from the needle. this detachment can lead to possible sample collection failure, and in exceptional circumstances, have the potential to cause a needle stick injury. the manufacturer has estimated that the frequency of this failure mode is 0.198%.
  • Action
    BD is providing instructions to allow the continued use the Vacutainer Eclipse Signal Blood Collection Needle with Integrated Holder: - Prior to use, ensure that the pink Eclipse Shield is positioned over the green or black needle cover. Grasp the needle cover and pink Eclipse Shield together and the holder in the other hand and pressing firmly down on the pink Eclipse Shield pull in a straight direction. Do not bend the device whilst pulling. - If the holder becomes detached, dispose of the device in an appropriate sharps collector. This action has been closed-out on 17/08/2016.

Device

BD Vacutainer Eclipse Signal Blood Collection Needle with Integrated Holder 21G & 22G.21G
  • Model / Serial
    BD Vacutainer Eclipse Signal Blood Collection Needle with Integrated Holder 21G & 22G.21GCatalogue Number : 368835 Lot/Batch Numbers4302105 4266252 4302106 4276343 4346490 4344023 4252010 5041109 4259413 5072433 22G Catalogue Number :368836 Lot/Batch Numbers 4268488 4346068 4302103 5027368 4346062ARTG Number: 128397
  • Manufacturer
    Becton Dickinson Pty Ltd

Manufacturer

Becton Dickinson Pty Ltd