Recall Z-0395-2016— Powers Medical Devices, LLC

Name: FDA recall Z-0395-2016
Creator: U.S. Food and Drug Administration
Published: 2015-10-01

Class II · Ongoing

Class II FDA medical device recall by Powers Medical Devices, LLC, initiated 2015-10-01. It names one FDA 510(k) clearance: K151050. 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.. 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)..

Recalling firm: Powers Medical Devices, LLC
Classification: Class II
Status: Ongoing
Initiated: 2015-10-01
Firm location: Delray Beach, FL, United States

510(k) clearances named in this recall

1 on FDA's record

K151050 — Pacifier Activated Lullaby (PAL®)Power Medical Devices, LLC·cleared 2015-12-22

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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.

Reason for recall

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).

Data sourced from openFDA. This site is unofficial and independent of the FDA.