Device Recall Terumo Cardiovascular Systems (CVS)

  • Modèle / numéro de série
    Lot Numbers: TD02, TD16
  • Distribution
    Nationwide Distribution including CA, CT , FL , WI.
  • Description du dispositif
    Terumo Custom Cardiovascular Procedure Kit X-Coated Perfusion Pack with FX25RE || P/N: 7928-03 || Terumo Cardiovascular Procedure Kits are manufactured and customized to the design and specifications of the purchaser and/or the purchaser's principal technical representative for the application intended by the end user. The kits are comprised of a variety of legally marketed medical devices [including Medivators HPH700 High Performance Hemoconcentrators]. The Hemocor HPH700 Hemoconcentrator is intended for use as an ultrafiltration system to remove excess fluid during and/or following cardiopulmonary bypass procedures where acute hemodilution has been employed
  • Manufacturer
  • 1 Event

Fabricant

  • Adresse du fabricant
    Terumo Cardiovascular Systems Corp, 28 Howe St, Ashland MA 01721-1305
  • Société-mère du fabricant (2017)
  • Source
    USFDA

4 dispositifs médicaux avec un nom similaire

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  • Modèle / numéro de série
    Lot Numbers: TD02
  • Distribution
    Nationwide Distribution including CA, CT , FL , WI.
  • Description du dispositif
    Terumo Custom Cardiovascular Procedure Kit X-Coated || Pediatric Pack || P/N: 74039-02 || Terumo Cardiovascular Procedure Kits are manufactured and customized to the design and specifications of the purchaser and/or the purchaser's principal technical representative for the application intended by the end user. The kits are comprised of a variety of legally marketed medical devices [including Medivators HPH700 High Performance Hemoconcentrators]. The Hemocor HPH700 Hemoconcentrator is intended for use as an ultrafiltration system to remove excess fluid during and/or following cardiopulmonary bypass procedures where acute hemodilution has been employed
  • Manufacturer
  • Modèle / numéro de série
    Lot Numbers: TD23
  • Distribution
    Nationwide Distribution including CA, CT , FL , WI.
  • Description du dispositif
    Terumo Custom Cardiovascular Procedure Kit X-Coated || Perfusion Pack || P/N: 74077-01 || Terumo Cardiovascular Procedure Kits are manufactured and customized to the design and specifications of the purchaser and/or the purchaser's principal technical representative for the application intended by the end user. The kits are comprised of a variety of legally marketed medical devices [including Medivators HPH700 High Performance Hemoconcentrators]. The Hemocor HPH700 Hemoconcentrator is intended for use as an ultrafiltration system to remove excess fluid during and/or following cardiopulmonary bypass procedures where acute hemodilution has been employed
  • Manufacturer
  • Modèle / numéro de série
    Lot Number: TD02
  • Distribution
    Nationwide Distribution including CA, CT , FL , WI.
  • Description du dispositif
    Terumo Custom Cardiovascular Procedure Kit X-Coated || PED/Adult Main Pack || P/N: 75185 || Terumo Cardiovascular Procedure Kits are manufactured and customized to the design and specifications of the purchaser and/or the purchaser's principal technical representative for the application intended by the end user. The kits are comprised of a variety of legally marketed medical devices [including Medivators HPH700 High Performance Hemoconcentrators]. The Hemocor HPH700 Hemoconcentrator is intended for use as an ultrafiltration system to remove excess fluid during and/or following cardiopulmonary bypass procedures where acute hemodilution has been employed
  • Manufacturer
  • Modèle / numéro de série
    Lot Number: TC23
  • Distribution
    Nationwide Distribution including CA, CT , FL , WI.
  • Description du dispositif
    Terumo Custom Cardiovascular Procedure Kit X-Coated || PED/Adult Main Pack || P/N: 75529 || Terumo Cardiovascular Procedure Kits are manufactured and customized to the design and specifications of the purchaser and/or the purchaser's principal technical representative for the application intended by the end user. The kits are comprised of a variety of legally marketed medical devices [including Medivators HPH700 High Performance Hemoconcentrators]. The Hemocor HPH700 Hemoconcentrator is intended for use as an ultrafiltration system to remove excess fluid during and/or following cardiopulmonary bypass procedures where acute hemodilution has been employed
  • Manufacturer