Events

Recall of Rusch Bronchopart Tube Set Left

According to New Zealand Medicines and Medical Devices Safety Authority, this recall involved a device in New Zealand that was produced by Rusch 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
    17809
  • Event Initiated Date
    2015-01-12
  • 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: Ebos Group Ltd, 14-18 Lovell Court, Rosedale, Auckland 0632
  • Reason
    Teleflex are recalling specific products following receipt of customer complaints reporting that the cobb connector detached from the main connector prior to use. this cobb connector detachment should be readily identified by the user during set-up and prior to use of the device. if during use, cobb connector separation occurs and presents as a leak in the breathing circuit and if it is unnoticed, then there is a remote probability that the patient may need to be re-intubated due to the risk of respiratory distress and hypoxia.
  • Action
    Product to be returned to supplier

Device

Rusch Bronchopart Tube Set Left
  • Model / Serial
    Model: Product Code: 116100-000260, Affected: 29 lots
  • Manufacturer
    Rusch Inc

Manufacturer

Rusch Inc