Palindrome HSI Chronic Catheter Kit

  • Model / Serial
    8888145048; 8888145048C; 8888145048CP; 8888145049; 8888145057; 8888145062; 8888145063; 8888145066; 8888145048C; 8888145048CP; 8888145049C; 8888145049CP; 8888145050C; 8888145050CP; 8888145057C; 8888145057CP; 888 | expiry date of February 2018 and earlier | See FSN
  • Product Description
    MD: Haemodialysis catheter, implantable
  • Manufacturer
  • 1 Event

Manufacturer

  • 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
    SATP

3 devices with a similar name

Learn more about the data here

  • Model / Serial
    Catalog Number: 8888145048 8888145048C 8888145048CP 8888145049 8888145049C 8888145049CP 8888145050 8888145050C 8888145050CP 8888145057 8888145057C 8888145057CP 8888145062 8888145063 8888145066 8888145066C
  • Product Description
    Inactive implantable medical devices
  • Manufacturer
  • Model / Serial
    Item codes identified with an expiry date of February 2018 and earlier
  • Product Classification
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Worldwide Distribution - US (nationwide) and Internationally to Argentina, Austria, Belgium, Brazil, Canada, Chile, China, Czech Republic, Denmark, Ecuador, Egypt, Finland, France, Germany, Greece, Hong, Kong, India, Iran, Ireland, Israel, Italy, Libya, Luxembourg, Malaysia, Mexico, Morocco, Netherlands, Norway, Oman, Panama, Philippines, Poland, Portugal, Saudi Arabia, Singapore, Slovakia, South Africa, Spain, Sweden, Switzerland, Turkey, Thailand, UAE, and United Kingdom.
  • Product Description
    Palindrome HSI Chronic Catheter Kit w/VenaTrac Stylet 14.5 Fr x 33cm || Item Code: 8888145050C
  • Manufacturer