Device recall
Z-0430-2013: 0.9% Sodium Chloride Injections, USP, 1000ml, VWR/Baxter Product Usage: The…
FDA device recall · Class II · Biomerieux Inc
Key facts
| Recall number (Z-number) | Z-0430-2013 |
|---|---|
| Recall event | 63479 |
| Product | 0.9% Sodium Chloride Injections, USP, 1000ml, VWR/Baxter Product Usage: The concentrated sodium chloride is used to prepare inoculum that is analyzed by the VITEK 2 instrument. The VITEK 2 user manual instructs all users to prepare inoculum with 0.45%-0.50% sodium chloride injections, and the system… |
| Recalling firm | Biomerieux Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Dec 5, 2013 |
| FEI number | 1950204 |
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