Device recall
Z-0085-2015: Baxter 2B8013 Empty INTRA VIA Container with PVC Ports (Sterile, nonpyrogenic…
FDA device recall · Class I · Baxter Healthcare Corp
Key facts
| Recall number (Z-number) | Z-0085-2015 |
|---|---|
| Recall event | 69181 |
| Product | Baxter 2B8013 Empty INTRA VIA Container with PVC Ports (Sterile, nonpyrogenic fluid path) ,500 ml. Admixture Products and Accessories The lntraVia Empty Plastic Container is intended for use in the preparation and administration of drug admixtures. |
| Product code | KPE |
| Recalling firm | Baxter Healthcare Corp |
| Recall class | Class I |
| Status | Terminated |
| Termination date | Jun 21, 2017 |
| 510(k) numbers | K964853 |
| FEI number | 1417572 |
At a glance
- 1–9 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