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The "Pacifier Activated Lullaby" (PAL) System composed of three major components: 1) the PAL Play...

FDA Device Recall #Z-0395-2016 — Class II — October 1, 2015

Recall Summary

Recall Number Z-0395-2016
Classification Class II — Moderate risk
Date Initiated October 1, 2015
Status Ongoing
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Powers Medical Devices, LLC
Location Delray Beach, FL
Product Type Devices
Quantity Total of 128 units

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).

Distribution Pattern

Nationwide Distribution.

Lot / Code Information

Serial Numbers A1221, A1226 (Ship Date 07/2015); Serial Numbers A1061, A1250, A1251 (Ship Date 05/2015); Serial Number A1246 (Ship Date 04/2015); Serial Numbers A1245, A1244, A1042, A1243 (Ship Date 02/2015); Serial Number A1225 (Ship Date 01/2015); Serial Numbers A1241, A1242 (Ship Date 12/2014); Serial Number A1036 (Ship Date 11/2014); Serial Numbers A1229, A1247, A1224 (Ship Date 10/2014); Serial Numbers A1239, A1234, A1236, A1237, A1238, A1233, A1228, A1231, A1232, A1235 (Ship Date 09/2014); Serial Number A1227 (Ship Date 08/2014); Serial Number A1223 (Ship Date 07/2014); Serial Numbers A1218, A1220 (Ship Date 06/2014); Serial Numbers A1217, A1216, A1248 (Ship Date 04/2014); Serial Numbers A1214, A1064 (Ship Date 03/2014); Serial Numbers A1087, A1213 (Ship Date 01/2014); Serial Numbers A1201, A1203, A1204, A1205, A1206, A1209, A1210, A1211, A1212, A1094, A1200, A1207, A1091, A1092, A1093, A1201 (Ship Date 12/2013; Serial Numbers A1075, A1076, A1077, A1078, A1079, A1080, A1081, A1082, A1083, A1070, A1072, A1073, A1084, A1086, A1087, A1088, A1089, A1090, A1085 (Ship Date 11/2013); Serial Numbers A1022, A1044 (Ship Date 10/2013); Serial Number A1059 (Ship Date 09/2013); Serial Numbers A1021, A1060, A1062, A1063, A1065, A1066, A1067, A1069 (Ship Date 08/2013); Serial Numbers A1037, A1005, A1015, A1024, A1230, A1050, A1051, A1052, A1053, A1054, A1055, A1058, A1016, A1019, A1064, A1249 (Ship Date 07/2013); Serial Numbers A1006, A1020, A1004, A1023, A1021 (Ship Date 05/2013); Serial Numbers A1025, A1046, A1032 (Ship Date 04/2013); Serial Numbers A1038, A1049, A1029, A1026, A1035, A1039, A1036, A1031, A1030, A1028, A1027, A1034 (Ship Date 03/2013); Serial Number P11 (Ship Date 02/2013); Serial Number P-7 (Ship Date 11/2012); Serial Numbers A1013, P-8 (Ship Date 09/2012); Serial Numbers A1043, P-6, A1041, P-9 (Ship Date 07/2012);

Frequently Asked Questions

Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.

Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.

Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.

What Should You Do?

Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.

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