Device recall
Z-0996-2013: Medfusion Model 3500 Syringe Pump, Model #3500-415 and 3500-500. Intended for…
FDA device recall · Class II · Smiths Medical ASD, Inc.
Key facts
| Recall number (Z-number) | Z-0996-2013 |
|---|---|
| Recall event | 63621 |
| Product | Medfusion Model 3500 Syringe Pump, Model #3500-415 and 3500-500. Intended for use in critical care areas for the administration of fluids requiring precisely controlled infusion rates. |
| Product code | FRN |
| Recalling firm | Smiths Medical ASD, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Apr 11, 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