Recall of Applied Medical Vascular and Biliary Catheters

According to New Zealand Medicines and Medical Devices Safety Authority, this recall involved a device in New Zealand that was produced by Applied Medical Resources Corporation.

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
    13410
  • Event Initiated Date
    2012-08-28
  • Event Country
  • Event Source
    NZMMDSA
  • 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 advises there is potential for packaging particulate matter to reside on the product.
  • Action
    Product to be returned to supplier

Device

  • Model / Serial
    Model: Model Numbers: A4403, A4405, A4406, A4407, A4752, A4F00, A4F01, A4F02, A4F03, A4F04, A4F05, A4F06, A4F07, A4F08., Affected: 48 lots
  • Manufacturer

Manufacturer