Device recall
Z-0395-2016: The "Pacifier Activated Lullaby" (PAL) System composed of three major…
FDA device recall · Class II · Powers Medical Devices, LLC
Key facts
| Recall number (Z-number) | Z-0395-2016 |
|---|---|
| Recall event | 72436 |
| Product | The "Pacifier Activated Lullaby" (PAL) System composed of three major components: 1) the PAL Player Module (aka Player Unit), 2) the PAL Pacifier Sensor, and 3) power supply. The system is designed to encourage and reinforce effective non-nutritive sucking of premature infants. |
| Product code | HCC |
| Recalling firm | Powers Medical Devices, LLC |
| Recall class | Class II |
| Status | Open, Classified |
| 510(k) numbers | K151050 |
| FEI number | 3009199231 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 1–9 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