Device recall
Z-0272-2023: Medfusion Model 4000 Syringe Infusion Pump, with software versions V1.6.0 or…
FDA device recall · Class II · Smiths Medical ASD Inc.
Key facts
| Recall number (Z-number) | Z-0272-2023 |
|---|---|
| Recall event | 91052 |
| Product | Medfusion Model 4000 Syringe Infusion Pump, with software versions V1.6.0 or V1.6.1 that have implemented the Smart Pump Programming (SPP) feature in a clinical treatment environment. Used for infusion of fluids requiring precisely controlled infusion rates including blood or blood products, lipids… |
| Product code | FRN |
| Recalling firm | Smiths Medical ASD Inc. |
| Recall class | Class II |
| Status | Open, Classified |
| 510(k) numbers | K111386 |
| 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