Drug recall
The "Pacifier Activated Lullaby" (PAL) System composed of three major components: 1) the PAL Player Module…
FDA recall event 72436 · Class II · Powers Medical Devices, LLC
Key facts
| Event ID | 72436 |
|---|---|
| Recall numbers | Z-0395-2016 |
| Recalling firm | Powers Medical Devices, LLC |
| Product type | Devices |
| Products | 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… |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | PAL unit has undergone significant technological changes since the previous 510(k) and labeling is not consistent with the cleared indications of the 510(k). |
| Initiation date | Oct 1, 2015 |
| Report date | Dec 16, 2015 |
| City | Delray Beach |
| State | FL |
| Country | United States |
| FEI number | 3009199231 |
At a glance
- 1–9 Products in this recall
- 1–9 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: