Devices

Device Recall CVI (Cardiovascular Innovations)

  • Modèle / numéro de série
    Lot Numbers: XX-02-X; XXX-03-X; XXX-04-X; XXX-05-X; 356-05; 356-06; 360-06; 361-06; 024-07; 044-07; 045-07; 046-07, where X is any number.
  • Classification du dispositif
    Cardiovascular Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide, including USA, Canada, Netherlands, and Germany.
  • Description du dispositif
    CVI OZ Palm Injector, used to perfuse contrast media into vessels for angiographic procedures. Ref : OZ 1035 (Cardiovascular Innovations LLC)
  • Manufacturer
    Lemaitre Vascular, Inc.
  • 1 Event

Fabricant

Lemaitre Vascular, Inc.
  • Adresse du fabricant
    Lemaitre Vascular, Inc., 63 Second Avenue, Burlington MA 01803-4413
  • Source
    USFDA