Events

Recall of Device Recall Covidien

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Covidien LLC.

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
    71784
  • Event Risk Class
    Class 2
  • Event Number
    Z-2443-2015
  • Event Initiated Date
    2015-07-31
  • Event Date Posted
    2015-08-21
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-05-31
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=139095
  • 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
    Infant heel warmer (chemical heat pack) - Product Code MPO
  • Reason
    Infant heel warmers may break during activation resulting in spillage of the contents on patients or healthcare worker causing potential skin/eye irritations.
  • Action
    Medtronic/Covidien issued an Urgent Medical Device recall letter dated July 31, 2015 via mailed Certified. The letter identified the affected product, problem and actions to be taken. The letter instructed customers to quarantine and discontinue use of the affected products.. For questions or concerns,contact Medtronic representative or Customer Service at (800)-882-5878.

Device

Device Recall Covidien
  • Model / Serial
    Lot Codes: 312209X 313033X 313304X 314307X 315108X 318417X 322119X 322514X 322817X
  • Product Classification
    Physical Medicine Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - US Nationwide and the countries: Canada, Mexico, Panama, and Japan.
  • Product Description
    Covidien Argyle Infant Heel Warmers (no tab) || Item Code: MH00002N || Product Usage: Intended for application of the right amount of heat to an infants heel for blood sampling
  • Manufacturer
    Covidien LLC

Manufacturer

Covidien LLC
  • Manufacturer Address
    Covidien LLC, 60 Middletown Ave, North Haven CT 06473-3908
  • 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