Device recall
Z-0577-2012: University of Mannheim DBS Collection Kit, Product K8308, each kit packed in a…
FDA device recall · Class II · Heritage Labs International LLC
Key facts
| Recall number (Z-number) | Z-0577-2012 |
|---|---|
| Recall event | 57863 |
| Product | University of Mannheim DBS Collection Kit, Product K8308, each kit packed in a bag or envelope and contains 1 Triad Medium Alcohol Prep Pad, Cat. No. 10-3001, NDC 50730-3001-0, blood specimen collection supplies and instructions. Blood specimen collection |
| Product code | LCP |
| Recalling firm | Heritage Labs International LLC |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Dec 26, 2012 |
| 510(k) numbers | K990899 |
| FEI number | 1000118383 |
At a glance
- 1–9 Linked 510(k)s
- 10–99 Products in the same recall event
- 100–999 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