Perfusion tubing Set

  • Model / Serial
    Model Lot Numbers Lot Number HY2W85R9 209704344,209704345,209704346,  209704347,210010558    TL7M64R3 209789393 TL7P17R1 209789333
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution including US: AL, IL, IN, and WI.
  • Product Description
    Medtronic Perfusion Tubing Packs, Models TL7M64R3, TL7P17R1 & HY2W85R9, Sterilized using Ethylene Oxide. || The Tubing Pack design and components are specified by the user, they are packaged with consideration of setup efficiency and respect for the environment, and they are intended for use in the extracorporeal circuit during cardiopulmonary bypass procedures. Medtronic Tubing Packs can contain components with Carmeda BioActive Surface, Trillium BioSurface, Balance BioSurface or no coating. Sterile barrier for these packs is provided either by a Tyvek lid seal on the tray or by a header bag.
  • Manufacturer
  • 1 Event

Manufacturer

  • Manufacturer Address
    Medtronic Perfusion Systems, 7611 Northland Dr N, Brooklyn Park MN 55428-1088
  • 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

24 devices with a similar name

Learn more about the data here

  • Model / Serial
    Lot No. 1010400032, 1015800061, 1016500044, 1017300020, 1022100041, 1022900026
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide distribution: CA, FL, IL, IN, KS, MD, MO, NE, NJ, NM, TN, TX, and VA.
  • Product Description
    Sorin OptiPack, Perfusion Tubing Set, Sterile EO, REF 082500600, Manufactured by Sorin Group USA, Inc. 14401 W. 65th Way Arvada, CO 80004 || Indicated for use in surgical procedures requiring extracorporeal support for periods of up to six hours.
  • Manufacturer
  • Model / Serial
    Lot No. 1020100025
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide distribution: CA, FL, IL, IN, KS, MD, MO, NE, NJ, NM, TN, TX, and VA.
  • Product Description
    Sorin OptiPack, Perfusion Tubing Set, Sterile EO, REF 084500201, Manufactured by Sorin Group USA, Inc. 14401 W. 65th Way Arvada, CO 80004 || Indicated for use in surgical procedures requiring extracorporeal support for periods of up to six hours.
  • Manufacturer
  • Model / Serial
    Lot No. 1024400046
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide distribution: CA, FL, IL, IN, KS, MD, MO, NE, NJ, NM, TN, TX, and VA.
  • Product Description
    Sorin OptiPack, Perfusion Tubing Set, Sterile EO, REF 084504800, Manufactured by Sorin Group USA, Inc. 14401 W. 65th Way Arvada, CO 80004 || Indicated for use in surgical procedures requiring extracorporeal support for periods of up to six hours.
  • Manufacturer
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