Device recall
Z-0490-2019: Irrisept OR, Finished Bottle Assembly 450 ml STEP 1
FDA device recall · Class II · Medex Cardio-Pulmonary Inc., d.b.a. Smiths Medical Company
Key facts
| Recall number (Z-number) | Z-0490-2019 |
|---|---|
| Recall event | 81399 |
| Product | Irrisept OR, Finished Bottle Assembly 450 ml STEP 1 |
| Product code | FQH |
| Recalling firm | Medex Cardio-Pulmonary Inc., d.b.a. Smiths Medical Company |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Sep 23, 2024 |
| 510(k) numbers | K080779 |
| FEI number | 1417519 |
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