Events

Recall of SHER-I-BRONCH ENDOBRONCHIAL TUBE KIT

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

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
    117544
  • Event Risk Class
    I
  • Event Initiated Date
    2015-06-09
  • 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
    Due to customer complaints reporting that the double swivel connector may crack or separate on the endobronchial tube. should this occur the device may leak causing a risk of respiratory distress or hypoxia that can in some cases lead to the need to re-intubate the patient.

Device

SHER-I-BRONCH ENDOBRONCHIAL TUBE KIT
  • Model / Serial
    Model Catalog: 5-16041 (Lot serial: > 10 lot numbers contact Mfg); Model Catalog: 5-16141 (Lot serial: > 10 lot numbers contact Mfg); Model Catalog: 5-16139 (Lot serial: > 10 lot numbers contact Mfg); Model Catalog: 5-16137 (Lot serial: > 10 lot numbers contact Mfg); Model Catalog: 5-16039 (Lot serial: > 10 lot numbers contact Mfg); Model Catalog: 5-16037 (Lot serial: > 10 lot numbers contact Mfg); Model Catalog: 5-16035 (Lot serial: > 10 lot numbers contact Mfg); Model Catalog: 5-16028 (Lot serial: > 10 lot numbers contact Mfg); Model Catalog: 5-16135 (Lot serial: > 10 lot numbers contact Mfg)
  • Product Classification
    Anesthesiology Devices
  • Product Description
    Hudson RCI Sheridan Sher-I-Bronch Endobronchial Tube
  • Manufacturer
    TRUDELL MEDICAL MARKETING LIMITED

Manufacturer

TRUDELL MEDICAL MARKETING LIMITED