Device recall
Z-1028-2011: ThermiSense model 5700-A5 The ThermiSense Model 5700-A5 is a nasal cannula that…
FDA device recall · Class II · Salter Laboratories, Division of Regulatory Affairs
Key facts
| Recall number (Z-number) | Z-1028-2011 |
|---|---|
| Recall event | 57504 |
| Product | ThermiSense model 5700-A5 The ThermiSense Model 5700-A5 is a nasal cannula that detects thermal variation during breathing cycles and transmits those variations to a remote Alice-5 Polysomnograph via electrical connectors to monitors an adult patient's breathing rate in a sleep laboratory study |
| Product code | BZQ |
| Recalling firm | Salter Laboratories, Division of Regulatory Affairs |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jun 6, 2011 |
| 510(k) numbers | K080922 |
| FEI number | 1314417 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 1–9 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