Device recall
Z-1484-2014: SIGMA SPECTRUM Volumetric Infusion Pump with Master Drug Library Product Usage…
FDA device recall · Class I · Baxter Healthcare Corp.
Key facts
| Recall number (Z-number) | Z-1484-2014 |
|---|---|
| Recall event | 67523 |
| Product | SIGMA SPECTRUM Volumetric Infusion Pump with Master Drug Library Product Usage: Sigma Spectrum Volumetric Infusion Pumps with Master Drug Library are intended to be used for the controlled administration of intravenous fluids. These fluids may include pharmaceutical drugs, blood, blood products and… |
| Product code | FRN |
| Recalling firm | Baxter Healthcare Corp. |
| Recall class | Class I |
| Status | Terminated |
| Termination date | May 25, 2017 |
| 510(k) numbers | K042121 |
| FEI number | 1417572 |
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