Device recall
Z-2394-2012: 0.9% Sodium Chloride Injection, USP, Pre-Filled Flush Solution, 10 mL in 12 mL…
FDA device recall · Class III · Amsino Medical USA
Key facts
| Recall number (Z-number) | Z-2394-2012 |
|---|---|
| Recall event | 63105 |
| Product | 0.9% Sodium Chloride Injection, USP, Pre-Filled Flush Solution, 10 mL in 12 mL Single Use Syringe, Rx only, List no. 1078-20, made in Nashville, TN, manufactured for Hospira, Inc., Lake Forest, IL 60045 USA. Flush syringe. |
| Product code | NGT |
| Recalling firm | Amsino Medical USA |
| Recall class | Class III |
| Status | Terminated |
| Termination date | Aug 13, 2013 |
| 510(k) numbers | K111034 |
| FEI number | 1000151124 |
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