Device recall
Z-1791-2009: The Alaris PC Unit, Model Numbers 8000 and 8015 (formerly Medley PC Unit)…
FDA device recall · Class I · Cardinal Health 303 dba Cardinal Health
Key facts
| Recall number (Z-number) | Z-1791-2009 |
|---|---|
| Recall event | 52119 |
| Product | The Alaris PC Unit, Model Numbers 8000 and 8015 (formerly Medley PC Unit) software version 8 and above when used with the Alaris PCA Module (Model 8120). The Alaris PC Unit is the central programming and power supply component for the Alaris System modules. |
| Product code | FRN |
| Recalling firm | Cardinal Health 303 dba Cardinal Health |
| Recall class | Class I |
| Status | Terminated |
| Termination date | Mar 19, 2012 |
| 510(k) numbers | K012383 |
| 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