Device recall
Z-3213-2017: UniPerc(R) Adjustable Flange Tracheostomy Tube kit, Reorder Number 100/897/080…
FDA device recall · Class II · Smiths Medical ASD Inc.
Key facts
| Recall number (Z-number) | Z-3213-2017 |
|---|---|
| Recall event | 77957 |
| Product | UniPerc(R) Adjustable Flange Tracheostomy Tube kit, Reorder Number 100/897/080 CZ The UniPerc(R) Tracheostomy Tubes can be used during the surgical placement of a stoma or as a replacement tube to an already existing stoma for patients with larger necks. The tracheostomy tubes are removed and may be… |
| Product code | JOH |
| Recalling firm | Smiths Medical ASD Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jun 18, 2019 |
| 510(k) numbers | K962175 |
| FEI number | 3012307300 |
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