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 number

Z-1075-2007

Recalling firm

Cardinal Health

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

Status

Terminated

Initiated

2007-06-01

Posted

2007-07-12

Terminated

2007-12-12

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.

Root cause

Other

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.

Quantity

48 units

Distribution

Nationwide.

Lot, serial or model codes

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

510(k) numbers

["K051226"]

PMA numbers

not on file

Product code

BZD

Firm FEI

3001236905

Firm city

Park

Firm state

IL

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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