🔍 RecallPedia

Powers Medical Devices

1 recall •
🏥 Medical Devices
• Categories: Infusion Pumps

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.

Class I - Dangerous

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).

Oct 1, 2015 Infusion Pumps Nationwide View Details →