Events

Recall of Device Recall AirLife 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
    38062
  • Event Risk Class
    Class 2
  • Event Number
    Z-1075-2007
  • Event Initiated Date
    2007-06-01
  • Event Date Posted
    2007-07-12
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2007-12-12
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=52879
  • 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
    continuous positive airway pressure device - Product Code BZD
  • Reason
    Under isolated conditions, the device may experience issues with o2 calibration, which may result in either a nuisance alarm or a delivered fio2 of up to 5% below the specified tolerance.
  • Action
    Cardinal Health sent the accounts recall letters dated 6/1/07 via UPS next day delivery, which listed the catalog number and affected serial numbers of the CPAP Driver, and informed them that under certain isolated conditions, the CPAP Driver may experience issues with O2 Calibration, which may result in either a nuisance alarm or a delivered FiO2 of up to 5% below the specified tolerance. Customers have experienced this under the following conditions: 1) air inlet pressure is greater than O2 pressure by 5 to 10 psi and 2) FiO2 settings less than 45%. Separate recall letters were sent to those accounts who had filed complaints of O2 Calibration Errors, stating that their device will be replaced by the end of June, 2007; those accounts who purchased the devices, but had not reported O2 Calibration Errors, stating that a Cardinal Health representative will upgrade the firmware on the devices at their facility by the end of August, 2007; and those accounts who had had demonstration units in their possession, advising them to notify their sales representative if any of the conditions mentioned in the letter occurred. 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, and were advised that they would be contacted by a Cardinal Health representative to arrange for the replacement/service of their drivers. Any questions were directed to Quality Systems-Professional Services at 1-800-292-9332 or 1-800-327-7503.

Device

Device Recall AirLife nCPAP System Driver
  • Model / Serial
    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
  • Product Classification
    Anesthesiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide.
  • Product Description
    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
    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