Events

Recall of Surgical Tissue Pouches

According to New Zealand Medicines and Medical Devices Safety Authority, this recall involved a device in New Zealand that was produced by Cook Incorporated.

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
    21481
  • Event Initiated Date
    2017-06-01
  • 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: Obex Medical Ltd, 303 Manukau Road, Epsom, AUCKLAND
  • Reason
    The reprocessing instructions do not provide sufficient detailed information for the cleaning, disinfection, and sterilisation of these products. preliminary investigation indicates that validation data related to the reprocessing of these devices do not meet the current guidance.
  • Action
    Product to be returned to supplier

Device

Surgical Tissue Pouches
  • Model / Serial
    Model: , Affected: Lapsac Introducer, G16500 All Lots, G15771 All Lots
  • Manufacturer
    Cook Incorporated

Manufacturer

Cook Incorporated