Device recall
Z-1414-04: The probes involved have been part of the Nellcor CapnoProbeTM SLS~1 Sublingual…
FDA device recall · Class I · Nellcor Puritan Bennett
Key facts
| Recall number (Z-number) | Z-1414-04 |
|---|---|
| Recall event | 29892 |
| Product | The probes involved have been part of the Nellcor CapnoProbeTM SLS~1 Sublingual System. The CapnoProbe system consists of an N-80 CapnoProbe device and an SLS-1 Sublingual Sensor, or probe. Each probe is packaged in a metal canister filled with a nonsterile buffered saline solution. The canister is… |
| Product code | CCK |
| Recalling firm | Nellcor Puritan Bennett |
| Recall class | Class I |
| Status | Terminated |
| Termination date | Dec 15, 2005 |
| 510(k) numbers | K010795 |
| FEI number | 2936999 |
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