Device recall
Z-1206-2012: Smiths Medical, Medfusion 3500 Syringe Pumps, Software version 5.0.0, Rx Only…
FDA device recall · Class II · Smiths Medical ASD, Inc.
Key facts
| Recall number (Z-number) | Z-1206-2012 |
|---|---|
| Recall event | 61273 |
| Product | Smiths Medical, Medfusion 3500 Syringe Pumps, Software version 5.0.0, Rx Only. These pumps are indicated for use by healthcare professionals in the delivery of IV solutions, drug solutions, blood or blood products, and enteral feedings in continuous, intermittent, and body weight delivery modes. |
| Product code | FRN |
| Recalling firm | Smiths Medical ASD, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jul 25, 2013 |
| 510(k) numbers | K040899 |
| FEI number | 2183502 |
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