Device recall
Z-1607-2008: EMD Chemicals, Harleco Brand Ethanol Standard, 1.0 mg/ml; 1.0 mg Ethanol in 1…
FDA device recall · Class III · EMD Chemicals Inc
Key facts
| Recall number (Z-number) | Z-1607-2008 |
|---|---|
| Recall event | 47528 |
| Product | EMD Chemicals, Harleco Brand Ethanol Standard, 1.0 mg/ml; 1.0 mg Ethanol in 1 ml, 10 ampules; Item number 68991/95; in vitro diagnostic. |
| Product code | DNN |
| Recalling firm | EMD Chemicals Inc |
| Recall class | Class III |
| Status | Terminated |
| Termination date | Sep 22, 2008 |
| 510(k) numbers | K990516 |
| FEI number | 2244894 |
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