Device recall
Z-2051-2020: Strep B Carrot Broth One-Step, 16x100mm Tube, 6ml, Item code Z46BX - Product…
FDA device recall · Class II · Cardinal Health Inc.
Key facts
| Recall number (Z-number) | Z-2051-2020 |
|---|---|
| Recall event | 85509 |
| Product | Strep B Carrot Broth One-Step, 16x100mm Tube, 6ml, Item code Z46BX - Product Usage: Intended to detect Group B Streptococcus (GBS) from anovaginal specimen collected from pregnant women. If pregnant woman is positive for GBS colonization, this will indicate a need for treatment prior to vaginal… |
| Product code | PQZ |
| Recalling firm | Cardinal Health Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jul 23, 2020 |
| 510(k) numbers | K170586 |
| FEI number | 3004008697 |
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