Device recall
Z-0222-2025: CADD-Solis Li-ion Rechargeable Battery Packs, REF 21-2160-XX, which are also…
FDA device recall · Class I · Smiths Medical ASD Inc.
Key facts
| Recall number (Z-number) | Z-0222-2025 |
|---|---|
| Recall event | 95287 |
| Product | CADD-Solis Li-ion Rechargeable Battery Packs, REF 21-2160-XX, which are also sold as a component of the following CADD Solis Ambulatory Infusion Systems: 21-2101-0100-50, 21-2101-0200-02, 21-2101-0200-03, 21-2101-0200-06, 21-2101-0200-07, 21-2101-0200-12, 21-2101-0200-14, 21-2101-0200-17… |
| Product code | FRN |
| Recalling firm | Smiths Medical ASD Inc. |
| Recall class | Class I |
| Status | Open, Classified |
| 510(k) numbers | K111275 |
| 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