Events

Recall of Terumo Trima Accel Automated Blood Collections System

According to New Zealand Medicines and Medical Devices Safety Authority, this recall involved a device in New Zealand that was produced by Terumo BCT 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
    14560
  • Event Initiated Date
    2013-05-01
  • 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: The Business Advisory Group Ltd, Level 13, 34 Shortland St, Auckland 1010
  • Reason
    Recall for product correction for the addition of a safety enhancement called air reduction mitigation (arm). this safety enhancement is being implemented to address the potential risk for air embolism should a donor be prematurely connected to the trimal accel system.
  • Action
    Software to be upgraded

Device

Terumo Trima Accel Automated Blood Collections System
  • Model / Serial
    Model: 81000, Affected: 1T05282
  • Manufacturer
    Terumo BCT Inc

Manufacturer

Terumo BCT Inc