Events

Recall of NASAL RAE PREFORMED TRACHEAL TUBE UNCUFFED

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by MALLINCKRODT 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
    34089
  • Event Risk Class
    I
  • Event Initiated Date
    2001-04-23
  • 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
    Possibility that a small plastic portion of the tube that is punched out to form murphy eye remained in place & could be aspirated into the trachea or a bronchus.

Device

NASAL RAE PREFORMED TRACHEAL TUBE UNCUFFED
  • Model / Serial
    Model Catalog: 86289 (Lot serial: M028570)
  • Product Description
    nasal rae tracheal tube 6mm lotm2870
  • Manufacturer
    MALLINCKRODT INC

Manufacturer

MALLINCKRODT INC
  • Manufacturer Address
    ST-LOUIS
  • Source
    HC