Events

Recall of SHILEY DISPOSABLE CANNULA TRACHEOSTOMY TUBE

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by COVIDIEN LP - RESPIRATORY & MONITORING SOLUTIONS GBU.

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
    152895
  • Event Risk Class
    I
  • Event Initiated Date
    2010-04-16
  • 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
    Manufacturer received customer reports of serious adverse health consequences that may be linked to certain cuffed shiley tracheostomy tubes in which the cuff does not hold air(leaks in the pilot balloon inflation assembly.

Device

SHILEY DISPOSABLE CANNULA TRACHEOSTOMY TUBE
  • Model / Serial
    Model Catalog: DCT (Lot serial: 0810002426 TO 0908000766 4DCT); Model Catalog: PERC (Lot serial: 0810002426 TO 0908000766 4DCT); Model Catalog: MDCT (Lot serial: 0812000028 TO 0908000232); Model Catalog: PERC (Lot serial: 0812000028 TO 0908000232); Model Catalog: DFEN (Lot serial: 0812000028 TO 0908000232); Model Catalog: DCT (Lot serial: 0812000028 TO 0908000232); Model Catalog: MDCT (Lot serial: FOR 10DFEN :); Model Catalog: PERC (Lot serial: FOR 10DFEN :); Model Catalog: DFEN (Lot serial: FOR 10DFEN :); Model Catalog: DCT (Lot serial: FOR 10DFEN :); Model Catalog: MDCT (Lot serial: 0911000199 TO 0911000221 MDCT); Model Catalog: PERC (Lot serial: 0911000199 TO 0911000221 MDCT); Model Catalog: DFEN (Lot serial: 0911000199 TO 0911000221 MDCT); Model Catalog: DCT (Lot serial: 0911000199 TO 0911000221 MDCT); Model Catalog: MDCT (Lot serial: 0810002453 TO 0908000797 8PERC); Model Catalog: PERC (Lot serial: 0810002453 TO 0908000797 8PERC); Model Catalog: DFEN (Lot serial: 0810002453 TO 0908000797 8PERC); Model C
  • Product Classification
    Anesthesiology Devices
  • Product Description
    SHILEY DISPOSABLE CANNULA TRACHEOSTOMY TUB
  • Manufacturer
    COVIDIEN LP - RESPIRATORY & MONITORING SOLUTIONS GBU

Manufacturer

COVIDIEN LP - RESPIRATORY & MONITORING SOLUTIONS GBU
  • Manufacturer Address
    BOULDER
  • Manufacturer Parent Company (2017)
    Medtronic plc
  • Manufacturer comment
    “If our surveillance systems identify a potential performance issue, our personnel promptly evaluate the problem, including, when appropriate, conducting root cause investigations and internal testing to assess whether the product continues to meet specifications and defined performance criteria,” Medtronic told ICIJ in a statement. “In some cases, based on this evaluation, Medtronic may determine that a recall is necessary.” The company said that it communicates with healthcare providers and/or patients and provide recommendations to address such issues. Medtronic noted that these communications can include letters, emails, calls, press releases, physician notifications and social media postings, as well as informing the FDA and other regulators of the actions.
  • Source
    HC