Events

Recall of Device Recall AirLife Infant nCPAP System Driver

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Cardinal Health.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    46294
  • Event Risk Class
    Class 2
  • Event Number
    Z-0987-2008
  • Event Initiated Date
    2008-01-04
  • Event Date Posted
    2008-05-14
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2009-01-09
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=67152
  • Notes / Alerts
    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.
  • Extra notes in the data
    Neonatal Incubator - Product Code BZD
  • Reason
    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.
  • Action
    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
  • Model / 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
  • Product Classification
    Anesthesiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution
  • Product Description
    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
  • Manufacturer Address
    Cardinal Health, 1430 Waukegan Rd, Mc Gaw Park IL 60085-6726
  • Manufacturer Parent Company (2017)
    Cardinal Health
  • Source
    USFDA