Device recall
Z-1508-2014: ToxCup Drug Screen Cup, Catalogue Numbers: HT15, HT15A, PT11, PT11A, PT15A…
FDA device recall · Class II · Branan Medical Corporation
Key facts
| Recall number (Z-number) | Z-1508-2014 |
|---|---|
| Recall event | 67818 |
| Product | ToxCup Drug Screen Cup, Catalogue Numbers: HT15, HT15A, PT11, PT11A, PT15A, PT23A, a screening device for the detection of drugs and drug metabolites in human urine. For in vitro diagnostic use only. |
| Product code | DIO |
| Recalling firm | Branan Medical Corporation |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jul 23, 2014 |
| 510(k) numbers | K032057 |
| FEI number | 3003102590 |
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