Recall of Applied Medical Laparoscopic Clip Applier

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
    19958
  • Event Initiated Date
    2016-04-05
  • 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: Applied Medical New Zealand Ltd, 6/56 Pavilion Drive, Mangere, Auckland 2022
  • Reason
    Manufacturer initiated recall of the ca090 direct drive® clip applier due to increased customer feedback indicating inconsistent clip application. although malformed clips are typically readily apparent to the user, this failure mode may lead to un-occluded vessels.
  • Action
    Product to be returned to supplier

Device

Manufacturer