Manufacturers

LivaNova USA

4 devices in the database

Stockert HeaterCooler System 3T
  • Model / Serial
    Serial #: a) 16S10743 - 6S11708  b) 16S10772 - 16S16840  C) 16S10958 - 16S16847
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    MN, TX, WA, OR, IL, OH, SC, AK, PA, CA, WI, GA, NJ, FL, AZ, KY, MS, MO, LA, AR, MA, MI, MT, CO, TN, NE, NC, VA, NV, HI, PR, WY, AL, OK, IN, CT, ME, IA, SC, KS, NM, SD, DC, MD, ND,
  • Product Description
    Sorin Stockert Heater-Cooler System 3T, || a) Item #: 16-02-81, 240 v/60 Hz; || b) Item #: 16-02-82, 208 v/60 Hz; || c) Item #: 16-02-85, 120 v/60 Hz
Device Recall INSPIRE 8 hollow fiber oxygenator with integrated hardshell venous/cardiotomy rese...
  • Model / Serial
    Lot:1709190230, UDI: (01)08033178112369(17)200917(10)1709190230, Exp: 09/17/2020; Lot: 1710260210, UDI: (01)08033178112369(17)201024(10)1710260210, Exp: 10/24/2020
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    US Distribution to the states of : NJ, CA, MN, MO, MA
  • Product Description
    Inspire 8 Integrated Phisio OXY w/ HVR Reservoir, Sterile EO, Catalog # 050714 || The intended uses for the two elements that constitute the oxygenator/reservoir integrated devices are: INSPIRE 8M Hollow Fiber Oxygenator: The INSPIRE 8M is intended for use in adult and small adult surgical procedures requiring cardiopulmonary bypass. It provides gas exchange support and blood temperature control. The INSPIRE 8M is intended to be used for 6 hours or less. INSPIRE HVR (Hardshell Venous/Cardiotomy Reservoir): The INSPIRE HVR is intended for use in adult and small adult surgical procedures requiring cardiopulmonary bypass. It collects, de-foams and filters venous blood and suction blood. INSPIRE HVR can be used post-operatively for chest drainage. The INSPIRE HVR is intended to be used for 6 hours or less.
Device Recall INSPIRE 6 hollow fiber oxygenator with integrated hardshell venous/cardiotomy rese...
  • Model / Serial
    Lot: 1709190228, UDI: (01)08033178112352(17)200917(10)1709190228, Exp: 09/17/2020
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    US Distribution to the states of : NJ, CA, MN, MO, MA
  • Product Description
    Inspire 6 Integrated Phisio OXY w/ HVR Reservoir, Sterile EO, Catalog # 050713 || The intended uses for the two elements that constitute the oxygenator/reservoir integrated devices are: INSPIRE 6M Hollow Fiber Oxygenator: The INSPIRE 6M is intended for use in adult and small adult surgical procedures requiring cardiopulmonary bypass. It provides gas exchange support and blood temperature control. The INSPIRE 6M is intended to be used for 6 hours or less. INSPIRE HVR (Hardshell Venous/Cardiotomy Reservoir): The INSPIRE HVR is intended for use in adult and small adult surgical procedures requiring cardiopulmonary bypass. It collects, de-foams and filters venous blood and suction blood. INSPIRE HVR can be used post-operatively for chest drainage. The INSPIRE HVR is intended to be used for 6 hours or less
Device Recall Sorin Group Smart Perfusion Pack EPack
  • Model / Serial
    Lot 1717800062, UDI (01)00803622108075(240)088511400(17)190630(10)1717800082; and Lot 1720800071, UDI (01)00803622108075(240)088511400(17)190731(10)1720800071
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Distribution was made to one consignee in LA.
  • Product Description
    Sorin Group Smart Perfusion Pack E-Pack, REF 088511400, Rev: L, Single Use, Sterile, Rx. The firm name on the label is Sorin Group USA, Inc., Arvada, CO.

2 manufacturers with a similar name

Learn more about the data here

LIVANOVA USA INC.
  • Manufacturer Address
    ARVADA
  • Source
    HC
LivaNova USA, Inc.