Events

Recall of Ferno Traction Splint

According to New Zealand Medicines and Medical Devices Safety Authority, this recall involved a device in New Zealand that was produced by Ferno-Washington 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
    19981
  • Event Initiated Date
    2016-04-05
  • 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: Pharmaco (NZ) Ltd, Level 1, 4 Fisher Crescent, Mt Wellington, AUCKLAND 1060
  • Reason
    The label on the outside clear plastic bag has been labelled as an adult splint strap set when in fact the product inside could possibly be a paediatric splint strap set. the only product pharmaco supplies is the adult straps for the adult traction splint.
  • Action
    Product to be exchanged

Device

Ferno Traction Splint
  • Model / Serial
    Model: 0822181 0822182 0822183 1590055 1590056 0313035 0313036, Affected:
  • Manufacturer
    Ferno-Washington Inc

Manufacturer

Ferno-Washington Inc