Events

Recall of Cooper Surgical Inflatoball Pessary

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
    21343
  • Event Initiated Date
    2017-04-28
  • 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 is recalling specific lots of its inflatoball pessary and inflatoball pessary kit products. these products are being recalled due to a labelling error on the secondary package. the current secondary package, a box, incorrectly states that the product is latex free. the product is made with 100% latex., the label on the package that contains the product and the ifu correctly states that the pessary is manufactured from latex rubber.
  • Action
    Product to be returned to supplier

Device

Cooper Surgical Inflatoball Pessary
  • Model / Serial
    Model: CO-MXPINFM and CO-MXPINFL, Affected: LOT NUMBER: 178321 and 185809
  • Manufacturer
    Cooper Surgical Inc

Manufacturer

Cooper Surgical Inc