Events

Recall of Rocket IPC Drainage System

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

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
    17559
  • Event Initiated Date
    2014-10-31
  • 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: Universal Specialities Ltd trading as USL Medical, 494 Rosebank Road, Avondale, AUCKLAND 1026
  • Reason
    A small number of drainage bottles have appeared to malfunction as the blue connector tube has not opened once the white clip has been moved. the non-opening of the blue tube does not allow the vacuum contained in the bottle to initiate drainage of fluid from the patient.
  • Action
    Manufacturer to issue advice regarding use

Device

Rocket IPC Drainage System
  • Model / Serial
    Model: R54400, R54400-00-PP, R54410, R51400, R51400-00-PP, R51410, Affected:
  • Manufacturer
    Rocket Medical PLC

Manufacturer

Rocket Medical PLC