Device recall
Z-1231-2025: BD Alaris Pump Module REF 8100 The BD Alaris System with Guardrails Suite MX is…
FDA device recall · Class II · CareFusion 303, Inc.
Key facts
| Recall number (Z-number) | Z-1231-2025 |
|---|---|
| Recall event | 96069 |
| Product | BD Alaris Pump Module REF 8100 The BD Alaris System with Guardrails Suite MX is a modular infusion pump and monitoring system for the continuous or intermittent administration of fluids to adult, pediatric, and neonatal patients through clinically accepted routes of administration |
| Product code | FRN |
| Recalling firm | CareFusion 303, Inc. |
| Recall class | Class II |
| 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
- 100–999 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