Events

Recall of Pasteur Pipettes for use in IVF

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Origio Australasia 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-2014-RN-00716-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2014-07-11
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-00716-1
  • 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
    Origio has identified a 'pinhole' packaging breach on the 3-pack pouched version of the pasteur pipets. as a result, the sterility of the package cannot be guaranteed.
  • Action
    Origio is requesting end users to return the affected lots of pastuer pipettes to their distributor for replacement or credit.

Device

Pasteur Pipettes for use in IVF
  • Model / Serial
    Pasteur Pipettes for use in IVFAffected product codes:PP-5.75-90, Box of 90, 30 pouches of 3 pipettes each , 5.75” (14.6cm) longPP-9-90, Box of 90, 30 pouches of 3 pipettes each, 9” (22.9cm) longPP-5.75-90PL, Box of 90, cotton plugged, 30 pouches of 3 pipettes each, 5.75” (14.6cm) long PP-9-90PL, box of 90, cotton plugged, 30 pouches of 3 pipettes each, 9” (22.9cm) long ARTG Number: 221911
  • Manufacturer
    Origio Australasia Pty Ltd

Manufacturer

Origio Australasia Pty Ltd
  • Source
    DHTGA