We use cookies to provide you with a better experience. By continuing to browse the site you are agreeing to our use of cookies in accordance with our Cookie Policy.
Accept
  • SKIP TO CONTENT
  • SKIP NAVIGATION
  • Drug News
    • Trending
    • Commercial Operations
    • GMPs
    • FDA Enforcement Actions
    • Inspections and Audits
    • Postmarket Safety
    • Quality
    • Regulatory Affairs
    • Research and Development
    • Submissions and Approvals
    • FDAnews Drug Weekly
    • FDAnews
  • Device News
    • Trending
    • Commercial Operations
    • FDA Enforcement Actions
    • Inspections and Audits
    • Postmarket Safety
    • Quality
    • Regulatory Affairs
    • Research and Development
    • Submissions and Approvals
    • FDAnews Device Weekly
    • FDAnews
  • Books
    • FDAnews Books Library
    • Drug Books
    • Device Books
  • Training/Events
    • Webinar Training Pass
    • Events
    • Webinar Recordings
  • Resources
    • Form 483s Database
    • FDA Approved Drugs
  • CenterWatch
  • About Us
    • The Company
    • FDAnews Editorial Board
    • Contact Us
  • Advertising
  • Sign In
  • Create Account
  • Sign Out
  • My Account
Home » TGA Investigates Heater-Cooler Devices

TGA Investigates Heater-Cooler Devices

Australia_FlagonMap.gif
May 24, 2017

Australia’s Therapeutic Goods Administration is conducting a product safety review of heater-cooler devices after five confirmed reports of Mycobacterium chimaera infections following heart surgery.

All the patient infections in Australia have been associated with Sorin Group’s Stockert 3T heater cooler devices manufactured before September 2014, the TGA said.

The following heater-cooler devices have been withdrawn from the Australian market: Zoll Circulation’s Coolgard; Chalice Medical’s Paratherm; Medos Medizintechnik’s DeltaStream; and Sorin Group’s Stockert Heater-Cooler 3T and Stockert Heater Cooler 1T.

The TGA is also investigating the following heater-cooler devices supplied to the Australian market: Zoll Circulation’s Thermogard XP; Maquet Australia’s HCU 20, 30, 25 and 40 series; and Paragon Healthcare’s Haemotherm CE 400.

View today's stories

Devices Postmarket Safety

    Upcoming Events

    • 05Dec

      Thriving in Clinical Research – Overcoming Common Challenges as a Site: Part 3 – Site Resourcing

    • 07Dec

      Proactive Supplier Management Using Quality Agreements

    • 13Dec

      FDA Inspection Overhaul: How Things Have Changed in 2023

    • 14Apr

      MAGI 2024: The Clinical Research Conference

    Featured Products

    • FDA, FTC and DOJ Enforcement of Medical Device Regulations

      FDA, FTC and DOJ Enforcement of Medical Device Regulations

    • Using Real-World Evidence in Drug and Device Submissions

      Using Real-World Evidence in Drug and Device Submissions

    Featured Stories

    • T-cell Malignancy From CAR-T Cell Immunotherapies Gets FDA Investigation

    • Vivos Sleep Apnea Oral Device Gets FDA Nod While Philips Wrestles With Yet Another CPAP Safety Issue

    • Novo Nordisk Battles Wegovy/Ozempic Pretenders and Faces Mounjaro’s Superior Study Results

    • Social, Emotional Risks Associated With Multi-Cancer Screening Discussed by Adcomm

    The Revised ICH E8: A Guide to New Clinical Trial Requirements

    Learn More
    • Drug Products
      • Quality
      • Regulatory Affairs
      • GMPs
      • Inspections and Audits
      • Postmarket Safety
      • Submissions and Approvals
      • Research and Development
      • Commercial Operations
    • Device Products
      • Quality
      • Regulatory Affairs
      • QSR
      • Inspections and Audits
      • Postmarket Safety
      • Submissions and Approvals
      • Research and Development
      • Commercial Operations
    • Clinical Products
      • Trial Design
      • Data Integrity
      • GCP
      • Inspections and Audits
      • Transparency
    • Privacy Policy
    • Do Not Sell or Share My Data
    Footer Logo

    300 N. Washington St., Suite 200, Falls Church, VA 22046, USA

    Phone 703.538.7600 – Toll free 888.838.5578

    Copyright © 2023. All Rights Reserved. Design, CMS, Hosting & Web Development :: ePublishing