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 1709500117
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide
  • Product Description
    STERILE SAMPLE SORIN GROUP, SMART PERFUSION PACK, NEONATE/PEDIATRIC PACK, REF 627127703, STERILE EO, Rx Only, 1 EA
  • Manufacturer
  • Model / Serial
    Lot Numbers: 1620000113, 1622400049, 1624300090, 1631200072, 1632100059, 1632800059, 1633300054, 1705100057, 1711500053
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide
  • Product Description
    SORIN GROUP, SMART PERFUSION PACK, NEONATE/PEDIATRIC PACK, REF 627127702, STERILE EO, Rx Only, 1 EA
  • Manufacturer
  • Model / Serial
    Lot Numbers: 1622100055, 1625200039, 1629800049
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide
  • Product Description
    SORIN GROUP, SMART PERFUSION PACK, TOTAL VISION SYSTEM-SMA, REF 084510101, STERILE EO, Rx Only, 1 EA
  • Manufacturer
  • Model / Serial
    Lot Number 1717300032
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide
  • Product Description
    SORIN GROUP, SMART PERFUSION PACK, INSPIRE 8S, REF 044036101, STERILE EO, Rx Only, 1 EA
  • Manufacturer
  • Model / Serial
    Lot Numbers: 1621400045, 1628600043
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide
  • Product Description
    SORIN GROUP, SMART PERFUSION PACK, SMART 1/4" PEDS PACK, REF 627262502, STERILE EO, Rx Only, 1 EA
  • Manufacturer
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