Device recall
Z-0653-2022: Medfusion Model 3500 and 4000 Syringe Infusion Pumps and Medfusion 3010 and…
FDA device recall · Class II · Smiths Medical ASD Inc.
Key facts
| Recall number (Z-number) | Z-0653-2022 |
|---|---|
| Recall event | 89144 |
| Product | Medfusion Model 3500 and 4000 Syringe Infusion Pumps and Medfusion 3010 and 3010A Syringe Infusion Pumps serviced during the same time period in which a main board was replaced using replacement main board part numbers G6000361, G6000435, G6001260, G6001560, G6001562 and G6002728. |
| Product code | FRN |
| Recalling firm | Smiths Medical ASD Inc. |
| Recall class | Class II |
| Status | Open, Classified |
| 510(k) numbers | K040899 |
| FEI number | 3012307300 |
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