Device recall
Z-2107-2012: Smiths Medical, Medfusion Syringe Infusion Pump, Model 4000, Software Version…
FDA device recall · Class I · Smiths Medical ASD, Inc.
Key facts
| Recall number (Z-number) | Z-2107-2012 |
|---|---|
| Recall event | 61247 |
| Product | Smiths Medical, Medfusion Syringe Infusion Pump, Model 4000, Software Version V1.0 & V1.1, Reorder Numbers 4000-0100-50, 4000-0100-95, 4000-0101-50, 4000-0101-51, and 4000-0101-78. Designed for use in care areas for the administration of fluids requiring precisely controlled infusion rates. |
| Product code | FRN |
| Recalling firm | Smiths Medical ASD, Inc. |
| Recall class | Class I |
| Status | Terminated |
| Termination date | Nov 14, 2012 |
| 510(k) numbers | K111386 |
| 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