Device recall
Z-1664-2018: Baxter Sigma Spectrum Infusion Pump with master Drug Library (Version 6)…
FDA device recall · Class II · Baxter Healthcare Corporation
Key facts
| Recall number (Z-number) | Z-1664-2018 |
|---|---|
| Recall event | 79815 |
| Product | Baxter Sigma Spectrum Infusion Pump with master Drug Library (Version 6) 35700BAXL Product Usage: The Baxter Sigma Spectrum Infusion Pump with master Drug Library is intended to be used for the controlled administration of fluids. These fluids may includes pharmaceutical drugs, blood, blood products… |
| Product code | FRN |
| Recalling firm | Baxter Healthcare Corporation |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Feb 14, 2020 |
| 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