Device recall
Z-0909-05: B-Sure brand one step home pregnancy test distributed by Harmony Brands Inc…
FDA device recall · Class II · Harmony Brands Llc
Key facts
| Recall number (Z-number) | Z-0909-05 |
|---|---|
| Recall event | 31500 |
| Product | B-Sure brand one step home pregnancy test distributed by Harmony Brands Inc., Melvindale, MI; Items 28030 (case of 48 kits) and 28031 (case of 144 kits). |
| Product code | LCX |
| Recalling firm | Harmony Brands Llc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Apr 17, 2007 |
| FEI number | 3003990373 |
At a glance
- None 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