Device recall
Z-2140-2016: The PCA 3 system cam be used in a wide range of clinical settings, including but…
FDA device recall · Class II · Hospira Inc.
Key facts
| Recall number (Z-number) | Z-2140-2016 |
|---|---|
| Recall event | 68318 |
| Product | The PCA 3 system cam be used in a wide range of clinical settings, including but not limited to: general floor, labor/delivery,post-partum, burn unit, medical surgical, operating room, oncology, critical care units, post-anesthesia care unit (PACU), and pediatrics. The PCA 3 infusion pump allows… |
| Product code | MEA |
| Recalling firm | Hospira Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Nov 7, 2016 |
| 510(k) numbers | K043256 |
| FEI number | 3013319212 |
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