Device recall
Z-1681-2025: CADD-Solis Infusion Pump Models: 1) PUMP KIT, CADD-SOLIS, MDL 2110, V4.2, CE…
FDA device recall · Class I · Smiths Medical ASD, Inc.
Key facts
| Recall number (Z-number) | Z-1681-2025 |
|---|---|
| Recall event | 96624 |
| Product | CADD-Solis Infusion Pump Models: 1) PUMP KIT, CADD-SOLIS, MDL 2110, V4.2, CE ENGLISH 1/EA, Model Number: 21-2111-0402-51; 2) PUMP KIT, CADD-SOLIS, MDL 2110, V4.2, YELLOW, CE ENGLISH 1/EA, Model Number: 21-2112-0402-51; 3) PUMP KIT, CADD-SOLIS, YELLOW, MODEL 2110 1/EA, Model Number: 21-2112-0100-51… |
| Product code | MEA |
| Recalling firm | Smiths Medical ASD, Inc. |
| Recall class | Class I |
| Status | Open, Classified |
| 510(k) numbers | K170982 |
| FEI number | 3012307300 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 10–99 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