CareFusion AirLife Heated Infant Breathing Circuit Product Usage:… — Class II medical device recall Z-2689-2014
Terminated recall by Carefusion 2200 Inc, reported 2014-10-01, distributed nationwide. The CareFusion AirLife Heated Infant Breathing Circuit is being recalled due to a regulatory compliance risk i
| Recall number | Z-2689-2014 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Carefusion 2200 Inc, Vernon Hills, IL, United States |
| Recall initiated | 2014-07-31 |
| Classified | 2014-09-23 |
| Reported by FDA | 2014-10-01 |
| Terminated | 2016-02-08 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA, CH, CN, KW, MX, SA |
| Quantity | 318,280 devices |
Product
CareFusion AirLife Heated Infant Breathing Circuit Product Usage: Respiratory breathing circuits are used with a ventilator when mechanical ventilation is administered to a patient.
Reason for recall
The CareFusion AirLife Heated Infant Breathing Circuit is being recalled due to a regulatory compliance risk involving a material change. The changes to the gas pathway may potentially impact the safety of the device and quality of the gas condensates to the 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-2689-2014. 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.