Events

Retiro De Equipo (Recall) de Device Recall AirLife Infant nCPAP System Driver

Según U.S. Food and Drug Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en United States que fue producido por Cardinal Health.

¿Qué es esto?

Una corrección al equipo o acción de retiro tomada por el fabricante para abordar un problema con un dispositivo médico. Los retiros (recalls) ocurren cuando un dispositivo médico está defectuoso, cuando puede poner en riesgo la salud, o cuando simultáneamente está defectuoso y puede poner en riesgo la salud.

Más información acerca de la data acá
  • Tipo de evento
    Recall
  • ID del evento
    46294
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0987-2008
  • Fecha de inicio del evento
    2008-01-04
  • Fecha de publicación del evento
    2008-05-14
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2009-01-09
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=67152
  • Notas / Alertas
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Notas adicionales en la data
    Neonatal Incubator - Product Code BZD
  • Causa
    Oxygen fluctuations - the airlife infant nasal cpap system exhibited o2 fluctuations when used with low o2 flow rates when the pto/auxillary port on the driver is used as a blender in administering o2 therapy via nasal cannula at flow rates of less than 4l/min.
  • Acción
    Cardinal Health sent an Urgent Medical Device Correction Notice dated 1/4/08 with a list of catalog number and affected serial numbers of the nCPAP Driver, and informed them that the nCPAP Driver may exhibited O2 fluctuations when used with low O2 flow rates when the PTO/Auxiliary port on the driver is used as a blender in administering O2 therapy via nasal cannula at flow rates of less than 4L/min. Customers were instructed to discontinue use of the PTO/Auxiliary port and were provided with a sticker reading "WARNINIG! DO NOT USE PTO/AUXILIARY PORT" that must be affixed to each unit in their possession. Sticker placement instructions and photo showing proper placement were provided with the letter. The accounts were informed that future upgrades to this device will eliminate the PTO/Auxiliary port and are expected to be completed in the field by June1, 2008. The accounts were requested to complete and return via fax at 847-689-9101, the enclosed acknowledgment form, indicating the number of affected drivers in their possession. Any questions were directed to Quality Systems-Professional Services at 1-800-292-9332 or 1-800-327-7503.

Device

Device Recall AirLife Infant nCPAP System Driver
  • Modelo / Serial
    Catalog Number 006900, Firmware Version 2.02.39 with the following Serial Numbers: 0107DL001, 0107DL002A, 0107DL003, 0107DL004A, 0107DL005, 0107DL006, 0107DL007, 0107DL008A, 0107DL009, 0107DL010, 0107DL011A, 0107DL012, 0107DL013, 0107DL014, 0107DL015, 0107DL016, 0107DL017, 0107DL018, 0107DL019, 0107DL020, 0107DL021, 0107DL022, 0107DL023, 0107DL024, 0107DL025, 0107DL026, 0107DL027, 0107DL028, 0107DL029, 0107DL030, 0206DL001, 0206DL002, 0206DL003, 0206DL004, 0206DL005, 0206DL006, 0207DL001, 0207DL002, 0207DL003, 0207DL004, 0207DL005, 0207DL006, 0306DL001, 0306DL002, 0306DL003, 0507DL007, 0507DL008, 0507DL009, 0507DL010, 0507DL011, 0507DL012, 0507DL013, 0507DL014, 0507DL015, 0507DL016, 0507DL017, 0507DL018, 0507DL019, 0507DL020, 0507DL021, 0507DL022, 0507DL023, 0507DL024, 0507DL025, 0507DL026, 0507DL027, 0507DL028, 0507DL029, 0507DL030, 0507DL031, 0507DL032, 0507DL033, 0507DL034, 0507DL035, 0507DL036, 0507DL037, 0507DL038, 0507DL039, 0507DL040, 0507DL041, 0507DL042, 0606DL001, 0606DL002A, 0606DL003, 0606DL004, 0606DL005, 0606DL006, 0606DL007, 0606DL008, 0606DL009A, 0606DL010, 0606DL011, 0606DL012A, 0606DL013, 0606DL014A, 0606DL015, 0606DL016, 0606DL017A, 0606DL018, 0606DL019A, 0606DL020, 0606DL021A, 0606DL022A, 0606DL023A, 0606DL024A, 0606DL025A, 0606DL026A, 0606DL027A, 0606DL028, 0606DL029, 0606DL030, 0606DL031, 0606DL032, 0606DL033A, 0606DL034, 0606DL035, 0606DL036, 0606DL037, 0606DL038, 0606DL039, 0606DL040, 0607DL043, 0607DL044, 0607DL045, 0607DL046, 0607DL047, 0607DL048, 0607DL049, 0607DL050, 0607DL051, 0607DL052, 0607DL053, 0607DL054, 0607DL055, 0607DL056, 0607DL057, 0607DL058, 0607DL059, 0607DL060, 0607DL061, 0607DL062, 0607DL063, 0607DL064, 0607DL065, 0607DL066, 0607DL067, 0607DL068, 0607DL069, 0607DL070, 0607DL071, 0607DL072, 0607DL073, 0607DL074, 0607DL075, 0607DL076, 0607DL077, 0607DL078, 0607DL079, 0607DL080, 0607DL081, 0607DL082, 0607DL083, 0607DL084, 0607DL085, 0607DL086, 0607DL087, 0607DL088, 0707DL089, 0707DL090, 0707DL091, 0707DL092, 0707DL093, 0707DL094, 0707DL095, 0707DL096, 0707DL097, 0707DL098, 0707DL099, 0707DL100, 0707DL101, 0707DL102, 0707DL103, 0707DL104, 0707DL105, 0707DL106, 0707DL107, 0707DL108, 0707DL109, 0707DL110, 0707DL111, 0707DL112, 0707DL113, 0707DL114, 0707DL115, 0707DL116, 0707DL117, 0707DL118, 0707DL119, 0707DL120, 0707DL121, 0707DL122, 0707DL123, 0707DL124, 0707DL125, 0707DL126, 0707DL127, 0707DL128, 0707DL129, 0707DL130, 0707DL131, 0707DL132, 0707DL133, 0707DL134, 0707DL135, 0707DL136, 0707DL137, 0707DL138, 0707DL139, 0707DL140, 1106DL001, 1106DL002, 1106DL003, 1106DL004, 1106DL005A, 1106DL006, 1106DL007A, 1106DL008, 1106DL009, 1106DL010A, 1106DL011, 1106DL012A, 1106DL013, 1106DL014A, 1106DL015A, 1106DL016, 1106DL017, 1106DL018, 1106DL019, 1106DL020, 1107DL133, 1107DL134, 1107DL135, 1107DL141, 1107DL142, 1107DL143, 1107DL144, 1107DL145, 1107DL146, 1107DL147, 1107DL148, 1107DL149, 1107DL150, 1107DL151, 1107DL152, 1107DL153, 1107DL154, 1107DL155, 1107DL156, 1107DL157, 1107DL158, 1107DL159, 1107DL160, 1107DL161, 1107DL162, 1107DL163, 1107DL164, 1107DL165, 1107DL166, 1206DL001A, 1206DL002A, 1206DL003A, 1206DL004A, 1206DL005A, 1206DL006A, 1206DL007A, 1206DL008A, 1206DL009A, 1206DL010, 1206DL011, 1206DL012A, 1206DL013A, 1206DL014, 1206DL015, 1206DL016A, 1206DL017, 1206DL018A, 1206DL019A, 1206DL020, 1206DL021, 1206DL022A, 1206DL023, 1206DL024, 1206DL025A, 1207DL167, 1207DL168, 1207DL169, 1207DL170, 1207DL171, 1207DL172, 1207DL173, 1207DL174, 1207DL175, 1207DL176, 1207DL177, 1207DL178, 1207DL179, 1207DL180, 1207DL181, 1207DL182, 1207DL183, 1207DL184, 1207DL185, 1207DL186, 1207DL187, 1207DL188, 1207DL189, 1207DL190, 1207DL191, 1207DL192, 1207DL193, 1207DL194, 1207DL195, 1207DL196, 1207DL198, and 1207DL199
  • Clasificación del producto
    Anesthesiology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Nationwide Distribution
  • Descripción del producto
    AirLife Infant nCPAP System Driver (Catalog No: 006900;) a nasal continuous positive airway pressure device, which is part of a larger system that includes an Infant Nasal CPAP generator, fixation device and patient interface (prongs and/or mask); Cardinal Health, McGaw Park, IL 60085
  • Manufacturer
    Cardinal Health

Manufacturer

Cardinal Health
  • Dirección del fabricante
    Cardinal Health, 1430 Waukegan Rd, Mc Gaw Park IL 60085-6726
  • Empresa matriz del fabricante (2017)
    Cardinal Health
  • Source
    USFDA