FDA Device recall Z-1900-2012
AirLife Isothermal Breathing Circuit, Infant Respiratory Circuit, Non-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, Non-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-1900-2012 |
| 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, Non-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 0260-503; 0778-503, 10392-503, 10416-503, 10448-507, 10734-503, 10852-503, 1209-503, 1535-503, 1853-503,…product codes 0260-503; 0778-503, 10392-503, 10416-503, 10448-507, 10734-503, 10852-503, 1209-503, 1535-503, 1853-503, 5599-503, 5643-503, 5898-503, 6189-503, 6800-503 and RC41-00097; 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-1900-2012%22
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