Device recall
Z-2613-2024: PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) PEDIATRIC TRACHEOSTOMY…
FDA device recall · Class I · Smiths Medical ASD Inc.
Key facts
| Recall number (Z-number) | Z-2613-2024 |
|---|---|
| Recall event | 94852 |
| Product | PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) PEDIATRIC TRACHEOSTOMY TUBE 2.5mm TTS FLEXTEND V NECK, Product Code/List Number/Item Code 67PFS25; b) PEDIATRIC TRACHEOSTOMY TUBE 3.0mm TTS FLEXTEND V NECK , Product Code/List Number/Item Code 67PFS30; c) PEDIATRIC TRACHEOSTOMY TUBE 3.5mm TTS… |
| Product code | BTO |
| Recalling firm | Smiths Medical ASD Inc. |
| Recall class | Class I |
| Status | Open, Classified |
| 510(k) numbers | K912469 |
| FEI number | 3012307300 |
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