Events

Recall of TRACOE TWIST TRACHEOSTOMY TUBE W/LOW PRESSURE CUFF AND SUCTION LINE

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by TRACOE MEDICAL GMBH.

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
    92386
  • Event Risk Class
    II
  • Event Initiated Date
    2017-10-12
  • Event Country
    Canada
  • Event Source
    HC
  • Notes / Alerts
    Canadian data is current through March 2018. All of the data comes from Health Canada, 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 Canada.
  • Extra notes in the data
  • Reason
    It was established at primary packaging that some obturators of one batch (size 06 lot 1000124104) can break when inserted into the outer cannula. there is a risk of broken fragments being inhaled into the lower respiratory tract.

Device

TRACOE TWIST TRACHEOSTOMY TUBE W/LOW PRESSURE CUFF AND SUCTION LINE
  • Model / Serial
    Model Catalog: 306-06 (Lot serial: 1000124104)
  • Product Description
    Tracoe Twist Tracheostomy Tube size 06
  • Manufacturer
    TRACOE MEDICAL GMBH

Manufacturer

TRACOE MEDICAL GMBH
  • Manufacturer Address
    NIEDER-OLM
  • Manufacturer Parent Company (2017)
    Xtr Group Gmbh
  • Source
    HC