Class II — Carefusion 2200 Inc
| Recalling firm | CAREFUSION |
|---|---|
| Registered facility | View this company's 4 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | 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. |
| 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. |
| Quantity | Approximately 318,280 devices |
| Distribution | Worldwide Distribution - US Nationwide in the states of AZ, CA, FL, IL, KY, LA, MI, MO, NE, NY, OH, OK, PA, RI, TN, TX, UT including Puerto Rico and the countries of Canada, China, Kuwait, Mexico, Saudi Arabia, and Switzerland. |
| Initiated | 2014-07-31 |
| Classified | 2014-09-23 |
| Terminated | 2016-02-08 |
| Recall number | Z-2689-2014 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Carefusion 2200 Inc (Z-2689-2014).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/68955/
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