FDA Device recall Z-1899-2012
AirLife Isothermal Breathing Circuit, Infant Respiratory Circuit, Heated
- FDA Device
- Class I
- terminated
- Published 2012-07-11
On 2012-07-11 the FDA classified a Class I recall of AirLife Isothermal Breathing Circuit, Infant Respiratory Circuit, Heated by Carefusion 2200, citing 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 deliver….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1899-2012 |
| Classification | Class I |
| Status | terminated |
| Initiated | 2012-05-29 |
| Published | 2012-07-11 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Carefusion 2200 |
| Distribution | US |
Product
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.
Reason
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.
Identifiers
| code_info | product codes 10127-4H1, 10331N-4S2, 10351-4H2, 10387-4S2, 10555-4S2, 10706-4S2, 10790-4S2, 10814-4S2, 10849-4S2, 1175-…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. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1899-2012%22
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