Events

Recall of Cook Hemospray Endoscopic Hemostat

According to New Zealand Medicines and Medical Devices Safety Authority, this recall involved a device in New Zealand that was produced by Wilson-Cook Medical 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
    16747
  • Event Initiated Date
    2014-05-27
  • 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
    Cook medical has received a small number of reports related to the inability to spray the powder for the hemospray endoscopic hemostat. these reports involve difficulty spraying the hemospray powder from the delivery system. adverse events that may occur due to spraying difficulties include inadequate treatment.
  • Action
    Product to be returned to supplier

Device

Cook Hemospray Endoscopic Hemostat
  • Model / Serial
    Model: Models: HEMO-7-EU, HEMO-10-EU, Affected: W3320783 (HEMO-7), and W3344464 (HEMO-10)
  • Manufacturer
    Wilson-Cook Medical Inc

Manufacturer

Wilson-Cook Medical Inc