Cardinal Health 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 Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
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
Brand
Cardinal Health
Lot Codes / Batch Numbers
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
Products Sold
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
Cardinal Health is recalling AirLife nCPAP System Driver; a nasal continuous positive airway pressure device, which is part of a due to 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. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026