Class II — Carefusion Corporation
| Recalling firm | CareFusion |
|---|---|
| Registered facility | BD SWITZERLAND SARL (the firm's only registered facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | The recall was initiated because Carefusion has identified potential risk associated with bolus programming with the Alaris PC unit (model 8015) software version 9.12. Automating infusion pump parameter input from either the electronic medical record (EMR) or the Alaris Auto-ID module for a continuous infusion with a bolus dose option may result in a loss of information from the Guardrails Data s |
| 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 | 4,090 total units |
| Distribution | Worldwide Distribution USA Nationwide and the countries of Australia and Canada. |
| Initiated | 2013-03-06 |
| Classified | 2013-04-14 |
| Terminated | 2014-05-08 |
| Recall number | Z-1112-2013 |
| 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 II recall — Carefusion Corporation (Z-1112-2013).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/64653/
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