Alaris PC unit model 8015 with software version 9 — Class II medical device recall Z-1112-2013
Terminated recall by Carefusion Corporation, reported 2013-04-24, distributed nationwide. The recall was initiated because Carefusion has identified potential risk associated with bolus programming wi
| Recall number | Z-1112-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Carefusion Corporation, San Diego, CA, United States |
| Recall initiated | 2013-03-06 |
| Classified | 2013-04-14 |
| Reported by FDA | 2013-04-24 |
| Terminated | 2014-05-08 |
| Distributed | Nationwide (US) |
| Countries outside the US | AU, CA |
| Quantity | 4,090 units |
| Reason classes | software |
| Model numbers | 8015 |
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
Reason for recall
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
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-1112-2013. 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.