Events

Recall of Cooper Surgical Milex Pessary Gellhorn

According to New Zealand Medicines and Medical Devices Safety Authority, this recall involved a device in New Zealand that was produced by Cooper Surgical 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
    14322
  • Event Initiated Date
    2013-03-12
  • 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: Downs Distributors Ltd, 9 Airborne Road, North Harbour, AUCKLAND
  • Reason
    The manufacturer advises the labels applied to the specified lots may no accurately reflect the size of the product contained in the packaging. the correct sizing is mouled into each pessary.
  • Action
    Product to be returned to supplier

Device

Cooper Surgical Milex Pessary Gellhorn
  • Model / Serial
    Model: Models: MXPGE2-3/4, MXPGE3-, Affected: Lots: 117560, 117568 (respectively)
  • Manufacturer
    Cooper Surgical Inc

Manufacturer

Cooper Surgical Inc