Events

Recall of Micro-Injection Pipettes for IVF procedures

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by William A Cook Australia 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-00679-1
  • Event Risk Class
    Class III
  • Event Initiated Date
    2014-06-26
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-00679-1
  • 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
    The listed devices are being recalled due to incorrect labelling of the product. specifically, micro-injection pipettes k-mpip-3135 have been placed into a shelf box identified as model k-mpip-3330. in addition, micro-injection pipettes k-mpip-3330 have been placed into a shelf box identified as model k-mpip-3135.
  • Action
    Cook Medical is requesting their customers to return any remaining affected product.

Device

Micro-Injection Pipettes for IVF procedures
  • Model / Serial
    Micro-Injection Pipettes for IVF proceduresProduct Number: K-MPIP-3135Lot Number: N118880Product Number: K-MPIP-3330Lot Number: N118800ARTG Number: 174653
  • Manufacturer
    William A Cook Australia Pty Ltd

Manufacturer

William A Cook Australia Pty Ltd