Class II — CareFusion 303, Inc.
| Recalling firm | CareFusion 303, INC. |
|---|---|
| Registered facility | View this company's 3 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | A patient weight can be populated incorrectly under certain conditions when using the RESTORE feature to restore infusions running on the Alaris LVP module model 8100 and the Alaris Syringe module model 8110. |
| Product | Alaris System PC Unit Model 8015 with software versions 9.17 and 9.19; Central programming, monitoring and power supply component for the Alaris System. |
| Quantity | 69,693 units |
| Distribution | Distributed US (nationwide) and in Canada. |
| Initiated | 2016-05-12 |
| Classified | 2016-06-28 |
| Terminated | 2018-12-24 |
| Recall number | Z-2064-2016 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — CareFusion 303, Inc. (Z-2064-2016).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/74142/
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