Device recall
Z-0768-06: TTS-400J Level1 Tympanic Temperature Sensor with 400 Series Thermistor
FDA device recall · Class II · Smiths Medical ASD, Inc.
Key facts
| Recall number (Z-number) | Z-0768-06 |
|---|---|
| Recall event | 34844 |
| Product | TTS-400J Level1 Tympanic Temperature Sensor with 400 Series Thermistor |
| Product code | FLL |
| Recalling firm | Smiths Medical ASD, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | May 30, 2012 |
| 510(k) numbers | K864195 |
| FEI number | 1221261 |
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