Events

Recall of Sydney IVF PVP (Used during microinjection techniques for reducing sperm motility to enable easier capture using a pipette)

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-2015-RN-00997-1
  • Event Risk Class
    Class III
  • Event Initiated Date
    2015-10-08
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-00997-1
  • 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
    This batch is being recalled as it was formulated with an excess of water, diluting the product outside the design specification. the batch met all of the release specifications, including mouse embryo assay; however, the effect of this dilution is a loss of viscosity, and creation of a hypo-osmotic environment for the sperm. this may make it difficult for the embryologist to capture the sperm, and may lead to swelling of the sperm tail.
  • Action
    Cook Medical is advising users to any discard remaining stock. Cook Medical will replace affected stock with a credit or replacement. This action has been closed-out on 04/03/2016.

Device

Sydney IVF PVP (Used during microinjection techniques for reducing sperm motility to enable easie...
  • Model / Serial
    Sydney IVF PVP (Used during microinjection techniques for reducing sperm motility to enable easier capture using a pipette) Product Code: K-SIPV-200-5 Bulk batch number M0615061ZLot Numbers: K22948, K22752, K22551, K22825, K22625, K23042 ARTG number 132688
  • Manufacturer
    William A Cook Australia Pty Ltd

Manufacturer

William A Cook Australia Pty Ltd