Cook, Inc.

One device in the database

  • Model / Serial
    All lots on the market as of 11/25/2002.
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    United States, Brazil, Canada, Dominican Republic and Israel.
  • Product Description
    COOK Stiffened Micropuncture¿ Introducer Set, 5 FR. || Product Reorder Number: MPIS-501-15.0-SC-NT-MKDT-090600

4 manufacturers with a similar name

Learn more about the data here

  • Manufacturer Address
    Cook, Inc., 750 Daniels Way, Bloomington IN 47404-9120
  • Source
    USFDA
  • Manufacturer comment
    Note published by the authorities from the Netherlands: This message is a warning from the manufacturer. After placing a medical device on the market, the manufacturer is obliged to follow the device and, where necessary, to improve it. When there is a risk for the user, the manufacturer must take action. The manufacturer informs users and the inspection of this action with a warning (Field Safety Notice). See also medical device warnings. This is part of the supervision of medical technology.
  • Source
    IGJ
  • Manufacturer Address
    Cook, Inc., 750 N Daniels Way, Bloomington IN 47404-9120
  • Manufacturer Parent Company (2017)
  • Source
    USFDA
  • 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
    MHM