Class I — Carefusion Corporation
| Recalling firm | CareFusion |
|---|---|
| Registered facility | BD SWITZERLAND SARL (the firm's only registered facility) |
| Classification | Class I |
| Status | Terminated |
| Reason | The recall was initiated because Carefusion has received reports of a communication error on the Alaris PC unit model 8015 with software version 9.12 when the Alaris EtCO2 module or Alaris SpO2 module is attached. |
| Product | Alaris PC unit model 8015 with software version 9.12 Product Usage: The Alaris PC unit is the central programming, monitoring and power supply component for the Alaris System. |
| Quantity | 9,241 units |
| Distribution | Worldwide Distribution - USA (nationwide) and the countries of Australia and China. |
| Initiated | 2013-03-06 |
| Classified | 2013-04-15 |
| Terminated | 2014-09-02 |
| Recall number | Z-1098-2013 |
| 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 I recall — Carefusion Corporation (Z-1098-2013).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/64728/
Alerts for CareFusion
Watchlist alerts will email you when FDA publishes a new recall, inspection classification, or warning letter for a facility you follow. They aren't open to the public yet — leave your email and we'll tell you when they are.
Want a one-page facility brief?
A single-page summary of this facility's registration and recall history for diligence. Not selling it yet — register interest and we'll follow up.