URIDRAIN Standard Male External Catheter

  • Model / Serial
    Lot Numbers: 030772764 109555264
  • Product Classification
  • 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
  • 1 Event

Manufacturer

  • Manufacturer Address
    Covidien LP, 15 Hampshire St, Mansfield MA 02048-1113
  • Manufacturer Parent Company (2017)
  • 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

One device with a similar name

Learn more about the data here

  • Model / Serial
    Lot Numbers: 016671464 019371364 022372464 023072264 027272564 032972964 034172164 100370964 103170664 106855364
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide distribution: USA (nationwide) and countries including: Canada and Bermuda.
  • Product Description
    URI-DRAIN Standard Male External Catheter with Two-Sided Adhesive Strap and Skin Protective Wipe || Product ID: 8884732500 || Intended use: Collector urine from male patients (and accessories) for indwelling catheter
  • Manufacturer