Device Recall Smart Perfusion Pack

  • Model / Serial
    Lot Number: 0932200096.
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    AZ, CA, FL, MO, NJ, SC, SD, TN, TX, UT, VA and WI.
  • Product Description
    Smart Perfusion Pack, REF: 088501900, Sterile EO, 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
  • 1 Event

Manufacturer

  • Manufacturer Address
    Sorin Group USA, Inc., 14401 W 65th Way, Arvada CO 80004
  • Manufacturer Parent Company (2017)
  • Source
    USFDA

29 devices with a similar name

Learn more about the data here

  • Model / Serial
    Lot Number: 0931600030.
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    AZ, CA, FL, MO, NJ, SC, SD, TN, TX, UT, VA and WI.
  • Product Description
    , REF: 084500500, Sterile EO, 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 Number: 0926600002
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    AZ, CA, FL, MO, NJ, SC, SD, TN, TX, UT, VA and WI.
  • Product Description
    Smart Perfusion Pack, REF: 086500300, Sterile EO, 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 Number: 0931600033
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    AZ, CA, FL, MO, NJ, SC, SD, TN, TX, UT, VA and WI.
  • Product Description
    Smart Perfusion Pack, REF: 086500301, Sterile EO, 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 Number: 0933600001
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    AZ, CA, FL, MO, NJ, SC, SD, TN, TX, UT, VA and WI.
  • Product Description
    Smart Perfusion Pack, REF: 086500600, Sterile EO, 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 Numbers: 0923000063, 0930100038, and 0923600036.
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    AZ, CA, FL, MO, NJ, SC, SD, TN, TX, UT, VA and WI.
  • Product Description
    Smart Perfusion Pack, REF: 088500700, Sterile EO, 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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