Food, drugs, devices › Carefusion Corporation
Device recall: Alaris PC unit model 8015 with software version 9.12 Product Usage: The Alaris PC unit is the central programming, monit
FDA enforcement event 64653 is a device recall by Carefusion Corporation of San Diego, CA, initiated 6 Mar 2013 and classified Class II, with 1 product record.
FDA defines Class II as a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. 90% of the 1,236 device enforcement events initiated in 2013 carry the same class.
Status: Terminated, terminated 8 May 2014. Initiation: voluntary: firm initiated. Carefusion Corporation has 3 enforcement events on this register, with a median of 1 product record per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
Carefusion Corporation, San Diego, CA.
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"
Distribution
"Worldwide Distribution USA Nationwide and the countries of Australia and Canada."
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-1112-2013 | 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 | 4,090 total units | Class II | Terminated | 24 Apr 2013 |
Context
Other enforcement events for Carefusion Corporation
| Initiated | Product (first record) | Type | Class | Records |
|---|---|---|---|---|
| 6 Mar 2013 | Alaris PC unit model 8015 with software version 9.12 Product Usage: The Alaris PC unit is the central programming, monit | Device | Class I | 1 |
| 20 Nov 2009 | Pyxis Anesthesia System Model 2000 (PAS 2000) Product Usage: The PAS 2000 is an anesthesia medication dispensing device | Device | Class II | 1 |
All 3 events for Carefusion Corporation
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall as: "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"
What does Class II mean?
FDA classifies recalls by relative degree of health hazard. Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
Where was the product distributed?
FDA's distribution pattern field reads: "Worldwide Distribution USA Nationwide and the countries of Australia and Canada."
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 8 May 2014. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.