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
This recall has been terminated (originally issued May 14, 2008).
- Company
- Cardinal Health
- Recall Initiated
- January 4, 2008
- Posted
- May 14, 2008
- Terminated
- January 9, 2009
- Recall Number
- Z-0987-2008
- Quantity
- 314 units
- Firm Location
- Mc Gaw Park, IL
- Official Source
- View on FDA website ↗
Reason for Recall
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.
Distribution
Nationwide Distribution
Lot / Code Info
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
Root Cause
Device Design
Action Taken
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.