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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
🏥 Medical Devices Recalled: October 1, 2015 Powers Medical Devices Infusion Pumps Nationwide

What Should You Do?

  1. Check if you have this product:
    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);
  2. Do not eat it: Even if it looks and smells fine, do not consume this product.
  3. Throw it away or return it: You can return the product to the store for a full refund.
  4. Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
  5. Report problems: Report any issues to the FDA's Safety Reporting Portal.

⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.

Recall Details

Company:
Powers Medical Devices, LLC
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).
Classification:
Class I - Dangerous

Dangerous or defective products that predictably could cause serious health problems or death.

Status:
ongoing

Product Information

Full 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.

Product Codes/Lot Numbers:

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);

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-0395-2016