Device recall
Z-3288-2011: FloTrak Elite modules FloTrak Elite P/N 1044971 FloTrak Elite P/N 1051005
FDA device recall · Class II · Respironics Novametrix, LLC.
Key facts
| Recall number (Z-number) | Z-3288-2011 |
|---|---|
| Recall event | 59312 |
| Product | FloTrak Elite modules FloTrak Elite P/N 1044971 FloTrak Elite P/N 1051005 |
| Product code | BZK |
| Recalling firm | Respironics Novametrix, LLC. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | May 23, 2012 |
| 510(k) numbers | K080652, K091459, K092217 |
| FEI number | 1219324 |
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