Events

Recall of EZ-Strip 145ìm (Assisted reproduction microtool)

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Key IVF Supplies.

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-2016-RN-01286-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2016-10-04
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-01286-1
  • 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
    It has been reported that an ez-strip product from the stated lot may contain debris that could result in the device failing to perform its intended purpose. this fault, if not identified by the customer could result in the loss of oocytes.
  • Action
    Key IVF Supplies are advising customers to cease use of the affected lot and immediately quarantine all remaining packs. Key IVF will arrange for the collection of the quarantined packs and will replace affected stock. This action has been closed-out on 02/03/2017.

Device

EZ-Strip 145ìm (Assisted reproduction microtool)
  • Model / Serial
    EZ-Strip 145ìm (Assisted reproduction microtool) Part Number: 7-72-1145/20Lot Number: 150299-01Expiry Date: June 2018
  • Manufacturer
    Key IVF Supplies

Manufacturer

Key IVF Supplies