Device recall
Z-0323-2018: Alaris PCA Pump, Model 8120. The firm name on the label is CareFusion. The…
FDA device recall · Class II · CareFusion 303, Inc.
Key facts
| Recall number (Z-number) | Z-0323-2018 |
|---|---|
| Recall event | 78588 |
| Product | Alaris PCA Pump, Model 8120. The firm name on the label is CareFusion. The Alaris Syringe Pump module and Alaris PCA module are infusion pump modules for the Alaris System. The syringe pump and PCA pump delivers medication or fluids in a manner similar to current syringe pumps on the market. The… |
| Product code | MEA |
| Recalling firm | CareFusion 303, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | May 4, 2020 |
| 510(k) numbers | K032233 |
| 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