Events

Recall of Ultradent Absorbent Point

According to New Zealand Medicines and Medical Devices Safety Authority, this recall involved a device in New Zealand that was produced by Ultradent Products Inc.

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
    21842
  • Event Initiated Date
    2017-08-21
  • Event Country
    New Zealand
  • Event Source
    NZMMDSA
  • Event Source URL
    https://medsafe.govt.nz/hot/Recalls/RecallSearch.asp
  • 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: Ultradent Products Australia Pty Ltd, 61 Reid Road, Glenbrook, RD1, Waiuku 2681
  • Reason
    The sterile packaging on the products was removed in order to place the product barcode underneath on the product container. this process created a non-sterile product when distributed. although no complaints have been received, it is recommended that these lots of absorbent paper points be discarded.
  • Action
    Product to be returned to supplier

Device

Ultradent Absorbent Point

Manufacturer

Ultradent Products Inc