Events

Recall of URIDRAIN Standard Male External Catheter

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

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
    58665
  • Event Risk Class
    Class 2
  • Event Number
    Z-2392-2011
  • Event Initiated Date
    2011-04-29
  • Event Date Posted
    2011-05-27
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2015-05-29
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=99860
  • 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
    Collector, urine, (and accessories) for indwelling catheter - Product Code KNX
  • Reason
    A component of the uri-drain device recalled the skin-prep (manufactured by h&p; industries-triad) a protective wipe due to bacterial contamination.
  • Action
    The firm, Covidien, sent an "URGENT PRODUCT RECALL" letter dated April 29, 2011 to its customers via US Postal Service. The letter described the product, problem and actions to be taken. The customers were instructed to immediately stop using the product, place in quarantine, and return any inventory. Distributors are requested to notify their customers. All customers are required to respond to the notice regardless of remaining inventory. Responses will be tracked for follow-up and effectiveness checks. For Customer Service questions regarding the recall please telephone: 1-800-962-9888 option 1 (weekdays, 8am to 6:30pm Eastern) and email to: sdfeedback@covidien.com. Should you have any medical questions concerning this recall, please call 508-261-6393.

Device

URIDRAIN Standard Male External Catheter
  • Model / Serial
    Lot Numbers: 030772764 109555264
  • Product Classification
    Gastroenterology-Urology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide distribution: USA (nationwide) and countries including: Canada and Bermuda.
  • Product Description
    URI-DRAIN Medium Male External Catheter With Two-Sided Adhesive Strap and Skin Protective Wipe || Product ID: 8884732000 || Intended use: Collector urine from male patients (and accessories) for indwelling catheter
  • Manufacturer
    Covidien LP

Manufacturer

Covidien LP
  • Manufacturer Address
    Covidien LP, 15 Hampshire St, 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