Device recall
Z-1649-2008: BCI Non Invasive Blood Pressure Monitor Product/Catalog number 6004,
FDA device recall · Class II · Smiths Medical PM, Inc.
Key facts
| Recall number (Z-number) | Z-1649-2008 |
|---|---|
| Recall event | 47800 |
| Product | BCI Non Invasive Blood Pressure Monitor Product/Catalog number 6004, |
| Product code | DXN |
| Recalling firm | Smiths Medical PM, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Dec 17, 2011 |
| 510(k) numbers | K031742, K984618 |
| FEI number | 2183502 |
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