Events

Recall of PhaSeal Secondary Set (C61)

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-2018-RN-00834-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2018-06-25
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2018-RN-00834-1
  • 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 received reports of leakage which could result in the potential exposure of hazardous drugs to the healthcare worker during preparation, transport or administration.This defect was noted by customers during product use. leakage was observed between the connector to the secondary set spike and the tubing to the spike joint. the defect cannot be detected by visual inspection only. 8 reports relating to this issue have been received in australia. to date, no reports of injury have been received in australia.
  • Action
    BD is advising customers to immediately review inventory and quarantine affected product. BD will arrange collection of affected stock from facilities.

Device

PhaSeal Secondary Set (C61)
  • Model / Serial
    PhaSeal Secondary Set (C61) Product code: 515302 Lot Number: 1005467 Distributed between 3/11/17 - 23/04/18ARTG Number: 299777(Becton Dickinson Pty Ltd - Basic intravenous administration set)
  • Manufacturer
    Becton Dickinson Pty Ltd

Manufacturer

Becton Dickinson Pty Ltd