Device recall
Z-1451-2015: Master Drug Library Software version 8.0, Product Code 35723V080, to be used…
FDA device recall · Class II · Baxter Healthcare Corp
Key facts
| Recall number (Z-number) | Z-1451-2015 |
|---|---|
| Recall event | 70658 |
| Product | Master Drug Library Software version 8.0, Product Code 35723V080, to be used with SIGMA Spectrum Infusion System (Pump) version 8.0, Product Code 35700BAX2 The SIGMA Spectrum Infusion Pump with Master Drug Library (MDL) is intended to be used for the controlled administration of fluids. |
| Product code | FRN |
| Recalling firm | Baxter Healthcare Corp |
| Recall class | Class II |
| Status | Terminated |
| Termination date | May 22, 2018 |
| 510(k) numbers | K133801 |
| 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