Recall of WACA Chorion Villus Biopsy Needle Set

According to New Zealand Medicines and Medical Devices Safety Authority, this recall involved a device in New Zealand 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
  • Event ID
  • Event Initiated Date
  • Event Country
  • Event Source
  • Event Source URL
  • Notes / Alerts
    Data from New Zealand is current through July 2018. All of the data comes from the New Zealand Medicines and Medical Devices Safety Authority, 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 New Zealand.
  • Extra notes in the data
    Recalling Organisation: Obex Medical Ltd, 303 Manukau Road, Epsom, AUCKLAND
  • Reason
    The manufacturer is initiating recall of the cook chorion villus biopsy needle set (echo tip) ck-k-cvns-1821-robinson-et. the diagram on the product label is incorrect. it shows that the 18ga needle has an echotip, and the 21ga does not, whereas the product is designed such that the 21ga needle has the echotip and the 18ga needle does not.
  • Action
    Product to be returned to supplier