Device recall
Z-2303-2013: Lactate Membrane units for E7077 Electrode Radiometer Medical ApS. The intended…
FDA device recall · Class II · Radiometer America Inc
Key facts
| Recall number (Z-number) | Z-2303-2013 |
|---|---|
| Recall event | 66108 |
| Product | Lactate Membrane units for E7077 Electrode Radiometer Medical ApS. The intended use is in vitro testing of samples of whole blood. |
| Product code | KHP |
| Recalling firm | Radiometer America Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Dec 24, 2013 |
| 510(k) numbers | K002290, K043218 |
| FEI number | 1523456 |
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