Device Recall Small Patient ECC Pack

  • Modèle / numéro de série
    Lot/batch No: 3000003260, Part number 701050175
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    US in the state of GA
  • Description du dispositif
    Small Patient ECC Pack, REF BEQ-TOP 24100, Product Usage: || The HLM Tubing Sets with Bioline Coating are for single use only. They may be sold sterile, non-sterile and bulk packed. Custom tubing sets that are sold sterile are not to be re-sterilized by the user. In open heart surgery the HLM Tubing Sets with Bioline Coating are used in combination with the heart-lung machine for the oxygenation of blood and removal of carbon dioxide. The main purpose of the HLM Tubing Sets with Bioline Coating is to connect the patient to the hear-lung machine and its components. The HLM Tubing Sets with Bioline Coating are therefore a component in the extracorporeal perfusion circulation system. The utilization period of the use of the tubing sets is restricted to six hours
  • Manufacturer
  • 1 Event

Fabricant

  • Adresse du fabricant
    Datascope Corporation, 15 Law Dr, Fairfield NJ 07004-0011
  • Société-mère du fabricant (2017)
  • Source
    USFDA