Device recall
Z-1712-2008: U9 Socket Integrated Circuit ("U9 IC") on the display board of the following…
FDA device recall · Class II · Cardinal Health 303 Inc DBA Alaris Products
Key facts
| Recall number (Z-number) | Z-1712-2008 |
|---|---|
| Recall event | 47335 |
| Product | U9 Socket Integrated Circuit ("U9 IC") on the display board of the following Alaris System modules built on or before October 4, 2005: (1) Alaris Syringe module (Model 8110) (a.k.a. Medley Syringe module) (2) Alaris PCA module (Model 8120) (a.k.a. Medley PCA module), CardinalHealth, San Diego, CA… |
| Product code | FRN |
| Recalling firm | Cardinal Health 303 Inc DBA Alaris Products |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Sep 13, 2011 |
| 510(k) numbers | K010966, K012383, K022677, K023264, K043299 |
| FEI number | 3003879246 |
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