CLASS I Device recall · Reported 11 Jul 2012 · FDA Enforcement Report
AirLife Isothermal Breathing Circuit recalled by Carefusion 2200
Carefusion 2200 is recalling AirLife Isothermal Breathing Circuit, Infant Respiratory Circuit, Heated, distributed nationwide in the US. The recall was initiated on 29 May 2012 and the FDA has classified it as Class I.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1899-2012
- FDA event ID
- 61943
- Recalling firm
- Carefusion 2200, McGaw Park, IL
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- 29 May 2012
- FDA classified
- 29 Jun 2012
- Reported
- 11 Jul 2012
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Packaging Defects
- Device type
- CPAP & Ventilators
Timeline
| 29 May 2012 | Recall initiated by company | |
| 29 Jun 2012 | Classified by FDA | +31 days |
| 11 Jul 2012 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
The Y adapter within the breathing circuit may spontaneously crack, causing a leak in the closed ventilation system. This leak could lead to a decrease in the tidal volume delivered to the ventilated patient.
Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.
Product as listed by the FDA
AirLife Isothermal Breathing Circuit, Infant Respiratory Circuit, Heated; an Rx device for single patient use; CareFusion, 22745 Savi Ranch Parkway, Yorba Linda, CA 92887 USA, Made in Mexico Respiratory breathing circuits are used with a ventilator when mechanical ventilation is administered to a patient.
Where it was distributed
Worldwide distribution: USA (nationwide) including Puerto Rico and internationally to: Canada, Egypt, France, Germany, Great Britain, Italy, Kuwait, Mexico, Portugal, Saudi Arabia, Spain, Taiwan and United Arab Emirates.
Questions about this recall
Why was it recalled?
The Y adapter within the breathing circuit may spontaneously crack, causing a leak in the closed ventilation system. This leak could lead to a decrease in the tidal volume delivered to the ventilated patient.
Which lots are affected?
product codes 10127-4H1, 10331N-4S2, 10351-4H2, 10387-4S2, 10555-4S2, 10706-4S2, 10790-4S2, 10814-4S2, 10849-4S2, 1175-4H2, 1208-4H1, 1553-4H1, 1815-409, 1998-4H1, 2119-4S2G, 2120-4S2G, 4319-4H2, 4326-4H2, 4652-5014677-4H2, 4875-4H2, 5665-4H2, 5682-409, 5732-4H1, 5868-4H2, 6002-4H2, 6040-501, 6074-4H1, 6198-4H2, 6274-H12, 6301-H12, 6313-501, 6459-4H2; 6485-4H2, 6588-4H2, 6942-4H2, 7100-4S2, 7147-4S2, 7156-4S2, 7184-4S2, 7206-4S2, 7213-4S2, 7354-4S2, 7395-4S2, 7407-4S2, 7441-4S2, 7483-4S2, 7526-4S2, 7575-4S2, 7582-4S2, 7588-4S2, 9053-4S2, 9054-4S2, 9055-4S2, 9056-4S2, 9058-4S2, RC41-12027, RC41-18039, RC41-18052, RC41-18060, RC51-12074, RC51-18004, RT4851-00, RT4851-12 and RT4851-18; includes all lot numbers of the affected product codes manufactured prior to February 3, 2012, lot #0000414257 and any lot numbers beginning with the letter Y.
Where was it sold?
Worldwide distribution: USA (nationwide) including Puerto Rico and internationally to: Canada, Egypt, France, Germany, Great Britain, Italy, Kuwait, Mexico, Portugal, Saudi Arabia, Spain, Taiwan and United Arab Emirates.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class I mean?
Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
2 other products · FDA event 61943This product is part of a recall event; the main page for the event is AirLife Isothermal Breathing Circuit Accessory recalled.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS I | AirLife Isothermal Breathing Circuit Accessory recalled | Carefusion 2200 | Packaging Defects | Nationwide | |
| CLASS I | AirLife Isothermal Breathing Circuit recalled by Carefusion 2200 | Carefusion 2200 | Packaging Defects | Nationwide |
More recalls from Carefusion 2200
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|---|---|---|---|---|---|
| Device | CLASS II | Medline Hudson Rci, Dbd-circuit,Vent,Inspiratory,Heated,Neo recalled | Medline Industries | Device Malfunction | Nationwide |
| Device | CLASS II | Getinge Y Sensor Module, Servo-u, Servo recalled | Maquet Critical Care AB | Device Malfunction | Nationwide |
| Device | CLASS II | Biofire Respiratory Panel 2.1 (RP2.1) recalled by BioFire Diagnostics | BioFire Diagnostics | Other | Nationwide |
| Device | CLASS I | Astral 100/150 Resmed Astral 100/50 is a ventilator system recalled | ResMed | Packaging Defects | Nationwide |
| Device | CLASS I | Breathing circuit set, coaxial recalled by Hamilton Medical AG | Hamilton Medical | Device Malfunction | Nationwide |