Device recall
Z-2012-2025: Caphosol Artificial Saliva (32 doses sachet box). 64 x 15 mL sachets aqueous…
FDA device recall · Class II · RECORDATI RARE DISEASES INC.
Key facts
| Recall number (Z-number) | Z-2012-2025 |
|---|---|
| Recall event | 97007 |
| Product | Caphosol Artificial Saliva (32 doses sachet box). 64 x 15 mL sachets aqueous solution (32 sachets Solution A Phosphate, 32 sachets Solution B Calcium) |
| Product code | LFD |
| Recalling firm | RECORDATI RARE DISEASES INC. |
| Recall class | Class II |
| Status | Open, Classified |
| 510(k) numbers | K234015 |
| FEI number | 3027554269 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 1–9 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