Food, drugs, devices › CareFusion Corporation
Device recall: Pyxis Anesthesia System Model 2000 (PAS 2000) Product Usage: The PAS 2000 is an anesthesia medication dispensing device
CareFusion Corporation (San Diego, CA) initiated this device recall on 20 Nov 2009; FDA lists 1 product record under event 53991, classified Class II.
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. 85% of the 26 device enforcement events initiated in 2009 carry the same class.
Status: Terminated, terminated 28 Mar 2013. 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 confirmed that when the PAS 2000 drawers due to inaccessability of drawers caused by system down time or lock-up."
Distribution
"Worldwide Distribution - USA (Nationwide) including CANADA."
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-1015-2013 | Pyxis Anesthesia System Model 2000 (PAS 2000) Product Usage: The PAS 2000 is an anesthesia medication dispensing device that provides medications and inventory management for the anesthesiologist at the point of care within the operating room. | 2637 | Class II | Terminated | 3 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 |
| 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 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 confirmed that when the PAS 2000 drawers due to inaccessability of drawers caused by system down time or lock-up."
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) including CANADA."
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 28 Mar 2013. "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.