Device recall
Z-2053-2016: Sodium Chloride Inhalation Solution, USP 3%, 60 x 4 mL Sterile Unit-Dose Vials…
FDA device recall · Class II · Nephron Pharmaceuticals Corp.
Key facts
| Recall number (Z-number) | Z-2053-2016 |
|---|---|
| Recall event | 73395 |
| Product | Sodium Chloride Inhalation Solution, USP 3%, 60 x 4 mL Sterile Unit-Dose Vials per carton, Rx Only, NDC 0487-9003-60. A vial contains sterile, preservation-free, clear, colorless, aqueous solution as labeled for induction of sputum production where specimen collection is indicated. For respiratory… |
| Product code | CAF |
| Recalling firm | Nephron Pharmaceuticals Corp. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jan 9, 2017 |
| 510(k) numbers | K120051 |
| FEI number | 3010892830 |
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