Device recall
Z-0008-2014: Draeger Fabius GS Premium, Fabius OS, Fabius Tiro, Fabius Tiro D-M Product…
FDA device recall · Class I · Draeger Medical, Inc.
Key facts
| Recall number (Z-number) | Z-0008-2014 |
|---|---|
| Recall event | 66025 |
| Product | Draeger Fabius GS Premium, Fabius OS, Fabius Tiro, Fabius Tiro D-M Product Usage: used to administer anesthesia and ventilation to patients during surgical procedures. |
| Product code | BSZ |
| Recalling firm | Draeger Medical, Inc. |
| Recall class | Class I |
| Status | Terminated |
| Termination date | Sep 23, 2014 |
| 510(k) numbers | K042419 |
| FEI number | 2517967 |
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