Device recall
Z-2826-2020: Alaris SpO2 Module Model 8210 and Model 8220 - Product Usage: is intended to…
FDA device recall · Class II · CareFusion 303, Inc.
Key facts
| Recall number (Z-number) | Z-2826-2020 |
|---|---|
| Recall event | 85919 |
| Product | Alaris SpO2 Module Model 8210 and Model 8220 - Product Usage: is intended to provide trained healthcare caregivers a way to automate the programming of infusion parameters, thereby decreasing the amount of manual steps necessary to enter infusion data. |
| Product code | FRN |
| Recalling firm | CareFusion 303, Inc. |
| Recall class | Class II |
| Status | Open, Classified |
| 510(k) numbers | K133532 |
| 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