Powers Medical Devices, LLC recalls The "Pacifier Activated Lullaby" (PAL) System composed of three major components: 1) the PAL Player Module (aka Player…

Recall date

October 1, 2015

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0395-2016

FDA classification

Class II

Brand / firm

Powers Medical Devices, LLC

Sold / distributed

Nationwide Distribution.

Why it was recalled

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).

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.