Device recall
Z-0631-06: Baxter Non-DEHP Micro-Volume Extension Set, product code 2N3345; An Rx sterile…
FDA device recall · Class II · Baxter Healthcare Corp.
Key facts
| Recall number (Z-number) | Z-0631-06 |
|---|---|
| Recall event | 34290 |
| Product | Baxter Non-DEHP Micro-Volume Extension Set, product code 2N3345; An Rx sterile, nonpyrogenic fluid pathway, 36'', 0.38mL Vol, with male Luer Lock adapter; Baxter Healthcare Corporation, Deerfield, IL 60015 U.S.A. |
| Product code | FPA |
| Recalling firm | Baxter Healthcare Corp. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Aug 18, 2008 |
| 510(k) numbers | K811463 |
| FEI number | 1416980 |
At a glance
- 1–9 Linked 510(k)s
- 10–99 Products in the same recall event
- 1,000+ 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