Device Recall Terumo Cardiovascular Procedure Kit

  • Model / Serial
    Lot Number: TE06
  • Distribution
    Nationwide Distribution including CA, CT , FL , WI.
  • Product Description
    Terumo Custom Cardiovascular Procedure Kit Tubing Pack || P/N: 66041-1 || 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

Manufacturer

  • Manufacturer Address
    Terumo Cardiovascular Systems Corp, 28 Howe St, Ashland MA 01721-1305
  • Manufacturer Parent Company (2017)
  • Source
    USFDA

One device with a similar name

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  • Model / Serial
    Lot Numbers: TD02,TD02A, TD23, TD23A
  • Distribution
    Nationwide Distribution including CA, CT , FL , WI.
  • Product Description
    Terumo Custom Cardiovascular Procedure Kit X-Coated Adult Pak || P/N: 73124 || 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