Device recall
Z-1101-2012: Oral-Eze (R) Oral Fluid Collection System, manufactured by Capitol Vial, Inc…
FDA device recall · Class II · Capitol Vial Inc
Key facts
| Recall number (Z-number) | Z-1101-2012 |
|---|---|
| Recall event | 60981 |
| Product | Oral-Eze (R) Oral Fluid Collection System, manufactured by Capitol Vial, Inc., Auburn, AL 36832 Product Usage: IVD for drugs of abuse |
| Product code | JKA |
| Recalling firm | Capitol Vial Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Aug 24, 2012 |
| 510(k) numbers | K984361 |
| FEI number | 3000325731 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 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