Events

Recall of Miramar Labs Mira Dry

According to New Zealand Medicines and Medical Devices Safety Authority, this recall involved a device in New Zealand that was produced by Miramar Labs 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
    19582
  • Event Initiated Date
    2015-12-18
  • 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: Device Consulting (NZ) Pty, Level 4, 52 Symonds Street, Auckland 1010
  • Reason
    Manufacturer has been advised that some clinics overseas are using substances that have not been validated for use with the miradry system to lubricate the skin prior to using the miradry handpiece. this may prevent the cooling plate in the miradry handpiece from correctly contain and cooling the skin and cause minor burns and blisters., whilst there have not been any adverse events reported in australia, device consulting is conducting a product correction to update the user manual for the miradry system to include the statement:, “do not use lubricants other than the recommended lubricants k-y® jelly or k-y® liquid). use of other substances such as ultrasound gel or ipl coupling gel can reduce the effectiveness of the surface cooling, leading to blisters or burns.”.
  • Action
    Instructions for use to be updated

Device

Miramar Labs Mira Dry

Manufacturer

Miramar Labs Inc