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Powers Medical Devices Recalls

1 recall on record · December 16, 2015 to December 16, 2015 · Medical Devices

December 16, 2015Medical DevicesFDA

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

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).

Powers Medical Devices Recalls | RecallWatchUSA