Events

Recall of Vital Signs Light Wand Stylet

According to New Zealand Medicines and Medical Devices Safety Authority, this recall involved a device in New Zealand that was produced by Vital Signs 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
    18361
  • Event Initiated Date
    2015-04-14
  • 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: Obex Medical Ltd, 303 Manukau Road, Epsom, AUCKLAND
  • Reason
    The outer pouch containing the 3910, light wand stylet may contain pin holes that may not be obvious to the user post-distribution of the product. the patient safety risk identified from such a compromise in package integrity means that the patient may be exposed to a non-sterile product.
  • Action
    Product to be returned to supplier

Device

Vital Signs Light Wand Stylet
  • Model / Serial
    Model: Product Code: VSI-3910, Affected: All lot numbers
  • Manufacturer
    Vital Signs Inc

Manufacturer

Vital Signs Inc