Device recall
Z-1304-2025: BD Alaris Systems Manager, REF 9601 Infusion Safety Management Software
FDA device recall · Class I · CareFusion 303, Inc.
Key facts
| Recall number (Z-number) | Z-1304-2025 |
|---|---|
| Recall event | 96323 |
| Product | BD Alaris Systems Manager , REF 9601 Infusion Safety Management Software |
| Product code | PHC |
| Recalling firm | CareFusion 303, Inc. |
| Recall class | Class I |
| Status | Open, Classified |
| 510(k) numbers | K211218 |
| FEI number | 2016493 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 10–99 Recalled products with this product code
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device recalls (products)
Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.
Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database