Device recall
Z-1811-2013: Sodium Bicarbonate, USP Provided bulk as raw material - label not applicable…
FDA device recall · Class II · Church & Dwight Inc
Key facts
| Recall number (Z-number) | Z-1811-2013 |
|---|---|
| Recall event | 65686 |
| Product | Sodium Bicarbonate, USP Provided bulk as raw material - label not applicable according to firm Dialysis Grade 1.5 Dialysis Grade 2 As an API or excipient in the manufacture of Medical Devices and Drugs |
| Recalling firm | Church & Dwight Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jun 30, 2015 |
| FEI number | 2280705 |
At a glance
- None Linked 510(k)s
- 1–9 Products in the same recall event
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