Device recall
Z-2138-2024: CODMAN BACTISEAL Clear EVD Catheter 1.9mm I.D. Catheter Set- indicated for…
FDA device recall · Class II · Integra LifeSciences Corp.
Key facts
| Recall number (Z-number) | Z-2138-2024 |
|---|---|
| Recall event | 94622 |
| Product | CODMAN BACTISEAL Clear EVD Catheter 1.9mm I.D. Catheter Set- indicated for gaining access to the ventricles of the brain and can be used with dimensionally compatible devices for draining cerebrospinal fluid (CSF) and other fluids of similar physical characteristics as a means of reducing… |
| Product code | JXG |
| Recalling firm | Integra LifeSciences Corp. |
| Recall class | Class II |
| Status | Open, Classified |
| 510(k) numbers | K233448 |
| FEI number | 3003418325 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 100–999 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