Device recall
Z-1237-2009: Alaris Patient-Controlled Analgesia (PCA) Module (formerly Medley PCA Module)…
FDA device recall · Class II · Cardinal Health 303 dba Cardinal Health
Key facts
| Recall number (Z-number) | Z-1237-2009 |
|---|---|
| Recall event | 51432 |
| Product | Alaris Patient-Controlled Analgesia (PCA) Module (formerly Medley PCA Module) Model 8120 used with the Alaris PC Unit with software versions 8 through 9.1. |
| Product code | FRN |
| Recalling firm | Cardinal Health 303 dba Cardinal Health |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jun 26, 2012 |
| 510(k) numbers | K012383, K032233 |
| 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