Device recall
Z-1490-2012: Sigma Spectrum VOLUMETRIC INFUSION PUMP, with or without Master Drug Library…
FDA device recall · Class I · Baxter Healthcare Corporation
Key facts
| Recall number (Z-number) | Z-1490-2012 |
|---|---|
| Recall event | 61355 |
| Product | Sigma Spectrum VOLUMETRIC INFUSION PUMP, with or without Master Drug Library, Part Number 35700 -- Common/Classification Name: Infusion Pump -- Class 2 medical device -- SIGMA LLC, Medina, NY 14103 Product Usage: The Spectrum Infusion Pump is intended to be used for the controlled administration of… |
| Product code | FRN |
| Recalling firm | Baxter Healthcare Corporation |
| Recall class | Class I |
| Status | Terminated |
| Termination date | Oct 17, 2017 |
| 510(k) numbers | K042121 |
| FEI number | 1314492 |
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