Device Recall Microstream SMART CAPNOLINE PLUS O2

Manufacturer

  • Manufacturer Address
    Oridion Medical 1987 Ltd., 7 Hamarpe St., P.O. Box 45025, Har Hotzvim Industrial Park, Jerusalem Israel
  • 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

2 devices with a similar name

Learn more about the data here

  • Model / Serial
    Lot numbers from Q0901006 to Q0908223. Produced between January and July 2009,
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    AZ, CA, FL, HI, LA, , MA, MO, NJ, OH, PA, WA, WI,
  • Product Description
    Microstream SMART CAPNOLINE PLUS O2 ADU/INT 25UN || Part Number: 009822 Oridion || 3012176-012 Physio Control
  • Manufacturer
  • Model / Serial
    Lot numbers from Q0901006 to Q0908223. Produced between January and July 2009,
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    AZ, CA, FL, HI, LA, , MA, MO, NJ, OH, PA, WA, WI,
  • Product Description
    Microstream SMART CAPNOLINE PLUS O2 LONG ADU/INT 25UN || Part Number: 009826
  • Manufacturer