Events

Recall of Device Recall Devon Supine, Lithotomy and Trendelenburg Positioning Kit

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
    68243
  • Event Risk Class
    Class 2
  • Event Number
    Z-1997-2014
  • Event Initiated Date
    2014-05-08
  • Event Date Posted
    2014-07-07
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2015-09-04
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=127205
  • 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
    Support, patient position - Product Code CCX
  • Reason
    Straps may separate from the foam pad.
  • Action
    Covidien Sales Representatives notified customers in person by beginning May 8, 2014. The Sales Representative will provided a copy of the Recall letter (attachment 4), and collect any remaining product at the site. The notification and recovery of the product is expected to be complete no later than May 14, 2014.

Device

Device Recall Devon Supine, Lithotomy and Trendelenburg Positioning Kit
  • Model / Serial
    14085, 14086, 14092, 14095, 14101, 14106  *The original recall submission listed 14084 and 14094, these were reported by Covidien in error on the original submission.
  • Product Classification
    Anesthesiology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    US Nationwide Distribution in the states of NJ, CA, TX, IL, MO, PA, OH, IN, MI, MN, FL, IN, DC, PA, VA, MS, ME, NV, AR, KY, NY, KS, SC
  • Product Description
    Devon Supine, Lithotomy and Trendelenburg Positioning Kit; Product Code: 31151090 || Product Usage: The device is intended to provide padding under the patient, and help maintain the position of an anesthetized patient during surgery.
  • Manufacturer
    Covidien LLC

Manufacturer

Covidien LLC
  • Manufacturer Address
    Covidien LLC, 15 Hampshire Street, Mansfield MA 02048-1113
  • 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