Device recall
Z-2295-2016: Babytherm 8004/8010, Infant Warmer, Class II device, 510 K K971198, Catalog #…
FDA device recall · Class II · Draeger Medical, Inc.
Key facts
| Recall number (Z-number) | Z-2295-2016 |
|---|---|
| Recall event | 74523 |
| Product | Babytherm 8004/8010, Infant Warmer, Class II device, 510 K K971198, Catalog # FR00105 (Babytherm 8010), 2M30404 (Babytherm 8004), non sterile, software controlled. Product Usage: Babytherm 8004/8010 is an open care infant warmer system for warming premature babies, neonates and infants with a body… |
| Product code | FMT |
| Recalling firm | Draeger Medical, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Dec 7, 2016 |
| 510(k) numbers | K971198 |
| FEI number | 2517967 |
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