Drug recall
Alaris PC unit model 8015 with software version 9.12 Product Usage: The Alaris PC unit is the central…
FDA recall event 64653 · Class II · Carefusion Corporation
Key facts
| Event ID | 64653 |
|---|---|
| Recall numbers | Z-1112-2013 |
| Recalling firm | Carefusion Corporation |
| Product type | Devices |
| Products | 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 |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| 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… |
| Initiation date | Mar 6, 2013 |
| Report date | Apr 24, 2013 |
| Termination date | May 8, 2014 |
| City | San Diego |
| State | CA |
| Country | United States |
| FEI number | 3009270278 |
At a glance
- 1–9 Products in this recall
- None FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: