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Powers Medical Devices, LLC recalls The "Pacifier Activated Lullaby" (PAL) System composed of three major components: 1) the PAL Player Module (aka Player U
Recalled December 16, 2015 · FDA recall Z-0395-2016 · Powers Medical Devices
Hazard
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). · FDA Class II
Units
Total of 128 units
Sold at
Nationwide Distribution.
Description
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).
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.
Manufacturer(s)
Powers Medical Devices, LLC
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →