Events

Recall of Welch Allyn KleenSpec Disposable Vaginal Speculum

According to New Zealand Medicines and Medical Devices Safety Authority, this recall involved a device in New Zealand that was produced by Welch Allyn 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
    13412
  • Event Initiated Date
    2012-09-03
  • 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: Universal Specialities Ltd trading as USL Medical, 494 Rosebank Road, Avondale, AUCKLAND 1026
  • Reason
    The manufacturer has updated their instructions for use to include warnings about potential for devices to be damaged in transit and the importance of examining the devices prior to use. the risk of a device breakage during use is estimated to be 1 in 6,000,000.
  • Action
    Manufacturer to issue advice regarding use

Device

Welch Allyn KleenSpec Disposable Vaginal Speculum
  • Model / Serial
    Model: All models, Affected: All lots
  • Manufacturer
    Welch Allyn Inc

Manufacturer

Welch Allyn Inc