Device recall
Z-2008-2009: Model 100 enFlow Fluid/Blood Warmer Model Numbers: 980100, 91000103, 91000153…
FDA device recall · Class II · Enginivity LLC
Key facts
| Recall number (Z-number) | Z-2008-2009 |
|---|---|
| Recall event | 52209 |
| Product | Model 100 enFlow Fluid/Blood Warmer Model Numbers: 980100, 91000103, 91000153, 91000154, 91000156 The device is a medical point-of-care device designed to warm blood and IV fluids. |
| Product code | LGZ |
| Recalling firm | Enginivity LLC |
| Recall class | Class II |
| Status | Terminated |
| Termination date | May 2, 2012 |
| 510(k) numbers | K060537 |
| FEI number | 3006095475 |
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