Events

Recall of Cooper Transwarmer Infant Transport Mattress

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
    18494
  • Event Initiated Date
    2015-05-11
  • 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: Pharmaco (NZ) Ltd, Level 1, 4 Fisher Crescent, Mt Wellington, AUCKLAND 1060
  • Reason
    Cooper surgical is advising users to discard or return any product that does not display a product lot code or expiration date on each individual unit. cooper surgical is aware that there may be product with customers that have been in inventory for more than five (5) years. some users of the transwarmer infant transport mattress may have removed individual units from the original packaging and have been using the device past the labelled and recommended expiration date.
  • Action
    Product to be returned to supplier

Device

Cooper Transwarmer Infant Transport Mattress
  • Model / Serial
    Model: Catalogue Number: 20421, Affected: All lots
  • Manufacturer
    Cooper Surgical Inc

Manufacturer

Cooper Surgical Inc