Device recall
Z-0534-2014: Alaris PC unit model 8000 and 8015 with Alaris PCA module model 8120 and Auto ID…
FDA device recall · Class I · CareFusion 303, Inc.
Key facts
| Recall number (Z-number) | Z-0534-2014 |
|---|---|
| Recall event | 66865 |
| Product | Alaris PC unit model 8000 and 8015 with Alaris PCA module model 8120 and Auto ID barcode scanner model 8600. Product Usage: The Alaris PC unit is the central programming, monitoring and power supply component for the Alaris System. The Alaris PCA (Patient Controlled Analgesia) pump is one of the… |
| Product code | FRN |
| Recalling firm | CareFusion 303, Inc. |
| Recall class | Class I |
| Status | Terminated |
| Termination date | Jun 2, 2016 |
| 510(k) numbers | K041241 |
| 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