Events

Recall of Cook Inc (Urology) Holmium Laser Fibres (Multi Use) (HLF-M)

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
    21403
  • Event Initiated Date
    2017-05-05
  • 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 manfacturer has identified that the reprocessing instructions do not provide sufficiently detailed information for the cleaning, disinfection, and sterilization of these products. the manufacturer preliminary investigation indicates that the validation data related to the reprocessing of these devices do not meet the current guidance.
  • Action
    Product to be returned to supplier

Device

Cook Inc (Urology) Holmium Laser Fibres (Multi Use) (HLF-M)
  • Model / Serial
    Model: , Affected: Catalogue number G48611 HLF-M273-CN, G48613 HLF-M365-CNV, G48615 HLF-M550-CNV All Lots
  • Manufacturer
    Cook Incorporated

Manufacturer

Cook Incorporated