Alaris PC unit model 8015 — Class II medical device recall Z-1811-2015
Terminated recall by CareFusion 303, Inc., reported 2015-06-24, distributed nationwide. An issue with the cancel functionality used during atypical infusion programming to cancel user inputted value
| Recall number | Z-1811-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | CareFusion 303, Inc., San Diego, CA, United States |
| Recall initiated | 2015-05-13 |
| Classified | 2015-06-16 |
| Reported by FDA | 2015-06-24 |
| Terminated | 2016-05-20 |
| Distributed | Nationwide (US) |
| Quantity | 63 units |
| Model numbers | 8015 |
Product
Alaris PC unit model 8015, Infusion pump. software version 9.17 Product Usage: The Alaris PC unit is the central programming, monitoring and power supply component for the Alaris System. The software is embedded in the Alaris PC unit.
Reason for recall
An issue with the cancel functionality used during atypical infusion programming to cancel user inputted values. An infusion may start that is greater than or less than the hospital established limits for the specific medication.
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-1811-2015. 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.