Device recall
Z-1387-06: Blood Gas and Co-Ox Electrolyte & Metabolyte Analyzers, ABL-800 series…
FDA device recall · Class II · Radiometer America Inc
Key facts
| Recall number (Z-number) | Z-1387-06 |
|---|---|
| Recall event | 34963 |
| Product | Blood Gas and Co-Ox Electrolyte & Metabolyte Analyzers, ABL-800 series, manufactured from 8/2004 through 9/2005. |
| Product code | JFP |
| Recalling firm | Radiometer America Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Apr 17, 2012 |
| 510(k) numbers | K041874 |
| FEI number | 1523456 |
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