Events

Recall of PORTEX ENDOTRACHEAL TUBE HOLDERS

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by SMITHS MEDICAL CANADA LTD. (SIMS).

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
    26679
  • Event Risk Class
    II
  • Event Initiated Date
    2014-07-09
  • 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
    A trend in complaints of difficulty in passing a suction catheter or locking the et tube holder in place was observed. smith medical's investigation determined that the fastener component and cylinder component on the et tube holder could cause compression of the tracheal tube when assembled together. the investigation determined that in some cases the fastener and cylinder could compress the tube enough to affect the tracheal tube inner diameter. customer feedback suggested that difficulty passing suction catheter usually occurred when a size 6fr suction catheter (or larger) was used.

Device

PORTEX ENDOTRACHEAL TUBE HOLDERS
  • Model / Serial
    Model Catalog: H4052 (Lot serial: >100 numbers contact mfg.); Model Catalog: H4051 (Lot serial: >100 numbers contact mfg.)
  • Product Description
    Portex Endotracheal Tube Holders Sizes 2.5mm and 3.0mm
  • Manufacturer
    SMITHS MEDICAL CANADA LTD. (SIMS)

Manufacturer

SMITHS MEDICAL CANADA LTD. (SIMS)
  • Manufacturer Address
    MARKHAM
  • Manufacturer Parent Company (2017)
    Smiths Group Plc
  • Source
    HC