AirLife Isothermal Breathing Circuit Accessory — Class I medical device recall Z-1901-2012
Terminated recall by Carefusion 2200 Inc, reported 2012-07-11, distributed nationwide. The Y adapter within the breathing circuit may spontaneously crack, causing a leak in the closed ventilation s
| Recall number | Z-1901-2012 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Carefusion 2200 Inc, McGaw Park, IL, United States |
| Recall initiated | 2012-05-29 |
| Classified | 2012-06-29 |
| Reported by FDA | 2012-07-11 |
| Terminated | 2016-01-22 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, CA, DE, EG, ES, FR, GB, IT, KW, MX, PT, SA, TW |
| Reason classes | packaging |
| Lot numbers | 0000414257 |
Product
AirLife Isothermal Breathing Circuit Accessory - Infant Patient Y Connector; an Rx device for single patient use; 30 connectors per box; 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 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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1901-2012. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.