Device Recall AirLife nCPAP System Driver

  • Modèle / numéro de série
    Catalog Number 006900, Firmware Version 2.02 with the following Serial Numbers: 0107DL002, 0107DL003, 0107DL004, 0107DL011, 0107DL008, 0606DL001, 0606DL002, 0606DL009, 0606DL012, 0606DL013, 0606DL014, 0606DL015, 0606DL017, 0606DL018, 0606DL019, 0606DL021, 0606DL022, 0606DL023, 0606DL024, 0606DL025, 0606DL026, 0606DL027, 0606DL033, 0606DL040, 1106DL001, 1106DL002, 1106DL003, 1106DL004, 1106DL005, 1106DL006, 1106DL007, 1106DL008, 1106DL009, 1106DL010, 1106DL011, 1106DL012, 1106DL013, 1106DL014, 1106DL015, 1106DL016, 1106DL017, 1106DL018, 1106DL019, 1106DL020, 1206DL001, 1206DL002, 1206DL003, 1206DL004, 1206DL005, 1206DL006, 1206DL007, 1206DL008, 1206DL009, 1206DL010, 1206DL011, 1206DL012, 1206DL013, 1206DL014, 1206DL015, 1206DL017, 1206DL018, 1206DL019, 1206DL020, 1206DL022, 1206DL023, 1206DL025, 1206DL016
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Nationwide.
  • Description du dispositif
    AirLife nCPAP System Driver; a nasal continuous positive airway pressure device, which is part of a larger system that includes an nCPAP generator, fixation device and patient interface (prongs and.or mask); Cardinal Health, McGaw Park, IL 60085; cat. 006900
  • Manufacturer
  • 1 Event

Fabricant

  • Adresse du fabricant
    Cardinal Health, 1430 Waukegan Rd, Mc Gaw Park IL 60085-6726
  • Société-mère du fabricant (2017)
  • Source
    USFDA