Events

Recall of Device Recall Shiley Neonatal, Pediatric and Long Pediatric Tracheostomy Tube with TaperGuard Cuff

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Covidien LP (formerly Nellcor Puritan Bennett 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
    71197
  • Event Risk Class
    Class 1
  • Event Number
    Z-1951-2015
  • Event Initiated Date
    2015-05-08
  • Event Date Posted
    2015-07-09
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-04-12
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=136460
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Tube tracheostomy and tube cuff - Product Code JOH
  • Reason
    Reports where patients who recently switched from the current shiley neonatal and pediatric products to the affected products experienced discomfort and in some cases, breathing difficulties, corresponding to a negative effect on oxygen levels.
  • Action
    Consignees were notified 5/8/15 via letter. Consignees were asked to return products.

Device

Device Recall Shiley Neonatal, Pediatric and Long Pediatric Tracheostomy Tube with TaperGuard Cuff
  • Model / Serial
    All products manufactured since 2/2012.
  • Product Classification
    Anesthesiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution. US nationwide, Canada, Australia, Belgium, Chile, Germany, Israel, Italy, Japan, Saudi Arabia, Singapore, South Africa, Turkey, and Uruguay.
  • Product Description
    Shiley Neonatal, Pediatric and Long Pediatric Tracheostomy Tube with TaperGuard Cuff. || Intended for use in providing tracheal access for airway managements.
  • Manufacturer
    Covidien LP (formerly Nellcor Puritan Bennett Inc.)

Manufacturer

Covidien LP (formerly Nellcor Puritan Bennett Inc.)
  • Manufacturer Address
    Covidien LP (formerly Nellcor Puritan Bennett Inc.), 6135 Gunbarrel Ave, Boulder CO 80301-3214
  • 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
    USFDA