Device recall
Z-1517-2015: The PCA 3 infusion pump allows clinicians, or patients, to (self) Administer…
FDA device recall · Class II · Hospira Inc.
Key facts
| Recall number (Z-number) | Z-1517-2015 |
|---|---|
| Recall event | 64225 |
| Product | The PCA 3 infusion pump allows clinicians, or patients, to (self) Administer analgesia safely and effectively within clinician programmed limits. |
| 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