Device recall
Z-0672-2017: V6 Rear Case Assembly, Product Code 35701, a replacement part for the SIGMA…
FDA device recall · Class II · Baxter Healthcare Corp.
Key facts
| Recall number (Z-number) | Z-0672-2017 |
|---|---|
| Recall event | 75311 |
| Product | V6 Rear Case Assembly, Product Code 35701, a replacement part for the SIGMA Spectrum Infusion Pump -- SIGMA LLC Medina, NY 14103 --- NOTE: The speakers are a part of the rear case assembly located in the back of the infusion pump. The speaker is intended to generate audible tones during each… |
| Product code | FRN |
| Recalling firm | Baxter Healthcare Corp. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jun 15, 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