Recall Z-0395-2016 · HCC Device, Biofeedback
Powers Medical Devices, LLC
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.
| Date | Oct 1, 2015 |
| Status | Open, Classified |
| Reason | 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). |
| Root cause | No Marketing Application |
| Action | Powers Medical Devices, LLC intends to notify customers via certified U.S. Mail and supply the updated Instruction Manual via U.S. Mail or other tracked service. Instructions to customers include: 1) destroy the previous Instruction Manual, and replace it with the new one provided, 2) attach the new product label over the existing labeling without covering up the Model # and serial # of the device, 3) certify the destruction and replacement of the Instruction Manual nd replacement of the product label to the company using the form and self-addressed stamped envelopw provided. |
| Quantity | Total of 128 units |
| Distribution | Nationwide Distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K151050 | Pacifier Activated Lullaby (PAL®) Power Medical Devices, LLC, Dec 22, 2015 |