Device recall
Z-1972-2012: enFlow IV Fluid Warmer (510k name: EFLOW IV FLUID WARMER, MODEL 100, EFLOW…
FDA device recall · Class II · Vital Signs Devices, a GE Healthcare Company
Key facts
| Recall number (Z-number) | Z-1972-2012 |
|---|---|
| Recall event | 62441 |
| Product | enFlow IV Fluid Warmer (510k name: EFLOW IV FLUID WARMER, MODEL 100, EFLOW DISPOSABLE CARTRIDGE, MODEL 200 AND EFLOW AC POWER SUPPLY, MODEL 120). The Enginivity enFlow TM IV Fluid Warmer is intended for warming blood, blood products and intravenous solutions prior to administration. It is intended… |
| Product code | LGZ |
| Recalling firm | Vital Signs Devices, a GE Healthcare Company |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Aug 19, 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