Device recall
Z-3040-2011: enFlow IV Fluid Warmer Part number 980105VS; (510K name: enFlow IV Fluid Warmer…
FDA device recall · Class II · Vital Signs Devices, a GE Healthcare Company
Key facts
| Recall number (Z-number) | Z-3040-2011 |
|---|---|
| Recall event | 59688 |
| Product | enFlow IV Fluid Warmer Part number 980105VS; (510K name: enFlow IV Fluid Warmer Model 100, EFlow Disposable Cartridge, Model 200 and EFlow AC Power Supply Model 120) Intended for warming blood, blood products, and intravenous solutions, prior to administration. Intended to be used by healthcare… |
| Product code | LGZ |
| Recalling firm | Vital Signs Devices, a GE Healthcare Company |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jun 14, 2013 |
| 510(k) numbers | K060537 |
| FEI number | 2242551 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 10–99 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