Device recall
Z-0719-2019: Portex Unit Dose 5 ml Normal Saline (0.9%)
FDA device recall · Class I · Medex Cardio-Pulmonary Inc., d.b.a. Smiths Medical Company
Key facts
| Recall number (Z-number) | Z-0719-2019 |
|---|---|
| Recall event | 81021 |
| Product | Portex Unit Dose 5 ml Normal Saline (0.9%) |
| Product code | CAF |
| Recalling firm | Medex Cardio-Pulmonary Inc., d.b.a. Smiths Medical Company |
| Recall class | Class I |
| Status | Terminated |
| Termination date | Apr 16, 2024 |
| 510(k) numbers | K820227 |
| FEI number | 1417519 |
At a glance
- 1–9 Linked 510(k)s
- 10–99 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