Device Recall Conducer Cardioplegia Set SITH MP4

  • Modèle / numéro de série
    Catalog Number: 165720 Lot Numbers: MDI5, MD15B, MD22, ME19, MP13. Manufacturing dates March 15, 20 I 0 through December 13, 20 I 0.  Catalog Number: 6375 Lot Numbers: MD15, ME19, MPI3  Manufacturing dates March 15, 2010 through December 13, 20 I 0
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution: US (nationwide) and the countries of Canada, Brazil, Hong Kong, Korea, and Thailand.
  • Description du dispositif
    Terumo Custom Cardioplegia Delivery Set- || Catalog Number:165720 and Catalog Number: 6375 || Product Usage: || Cardioplegia Delivery System that is designed to delivery blood/solution to the patient undergoing cardiopulmonary bypass surgery. The set is designed to deliver blood/solutions at a 4: I ratio. Includes a Conducer Heat Exchanger and a MP4 Temperature & Pressure Module. Additionally, the set is constructed with a female luer connector that is the subject of the correction/removal activity.
  • 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