Device recall
Z-2139-2016: The LifeCare PCA Plus II infusion pump system is designed for safe, effective…
FDA device recall · Class II · Hospira Inc.
Key facts
| Recall number (Z-number) | Z-2139-2016 |
|---|---|
| Recall event | 68318 |
| Product | The LifeCare PCA Plus II infusion pump system is designed for safe, effective, analgesic delivery to patients through the intravenous or epidural routes in a wide range of clinical settings, including ICU, CCU, SICU, trauma units, bone marrow transplant centers, burn units, oncology centers, and… |
| Product code | FRN |
| Recalling firm | Hospira Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Nov 7, 2016 |
| 510(k) numbers | K912928 |
| FEI number | 3013319212 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 100–999 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