Events

Recall of PER-FIT PERCUTANEOUS TRACHEOSTOMY KIT

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
    33305
  • Event Risk Class
    II
  • Event Initiated Date
    2005-05-24
  • 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
    Guiding catheters which have been discovered to have weakened sidewalls in the area around the black over molded "stop" which may compromise the devices resistance to breakage. the "stop" may become detached.

Device

PER-FIT PERCUTANEOUS TRACHEOSTOMY KIT
  • Model / Serial
    Model Catalog: 538090E (Lot serial: K510893); Model Catalog: 538070E (Lot serial: K518075 K520177 K548751); Model Catalog: 538080E (Lot serial: K510893); Model Catalog: 538070E (Lot serial: K510893); Model Catalog: 538090E (Lot serial: K510891 K510892 K565595); Model Catalog: 538080E (Lot serial: K510891 K510892 K565595); Model Catalog: 538070E (Lot serial: K510891 K510892 K565595); Model Catalog: 538090E (Lot serial: K586109 K614402 K629274); Model Catalog: 538080E (Lot serial: K586109 K614402 K629274); Model Catalog: 538070E (Lot serial: K586109 K614402 K629274); Model Catalog: 538090E (Lot serial: K515076 K518078 K558496); Model Catalog: 538080E (Lot serial: K515076 K518078 K558496); Model Catalog: 538070E (Lot serial: K515076 K518078 K558496); Model Catalog: 538090E (Lot serial: K559483 K614996 K630177); Model Catalog: 538080E (Lot serial: K559483 K614996 K630177); Model Catalog: 538070E (Lot serial: K559483 K614996 K630177); Model Catalog: 538090E (Lot serial: K523556 K527903 K548745); Model Catalog: 53
  • Product Description
    portex perfit percutaneous dilational
  • Manufacturer
    SMITHS MEDICAL CANADA LTD. (SIMS)

Manufacturer

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