Reported Dec 16, 2015 · Ongoing
The "Pacifier Activated Lullaby" (PAL) System composed of three major components
Powers Medical Devices, LLC
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Powers Medical Devices, LLC · 1615 S Congress Ave Ste 103 · Delray Beach, FL · 33445-6326
Is this the product you have?
The "Pacifier Activated Lullaby" (PAL) System composed of three major components
3 of 3 products
| # | Product as published |
|---|---|
| 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. |
- Lot codes and dates
28 of 28 products
Products covered by this recall # Product as published 1 Serial Numbers A1221, A1226 (Ship Date 07/2015) 2 Serial Numbers A1061, A1250, A1251 (Ship Date 05/2015) 3 Serial Number A1246 (Ship Date 04/2015) 4 Serial Numbers A1245, A1244, A1042, A1243 (Ship Date 02/2015) 5 Serial Number A1225 (Ship Date 01/2015) 6 Serial Numbers A1241, A1242 (Ship Date 12/2014) 7 Serial Number A1036 (Ship Date 11/2014) 8 Serial Numbers A1229, A1247, A1224 (Ship Date 10/2014) 9 Serial Numbers A1239, A1234, A1236, A1237, A1238, A1233, A1228, A1231, A1232, A1235 (Ship Date 09/2014) 10 Serial Number A1227 (Ship Date 08/2014) 11 Serial Number A1223 (Ship Date 07/2014) 12 Serial Numbers A1218, A1220 (Ship Date 06/2014) 13 Serial Numbers A1217, A1216, A1248 (Ship Date 04/2014) 14 Serial Numbers A1214, A1064 (Ship Date 03/2014) 15 Serial Numbers A1087, A1213 (Ship Date 01/2014) 16 Serial Numbers A1201, A1203, A1204, A1205, A1206, A1209, A1210, A1211, A1212, A1094, A1200, A1207, A1091, A1092, A1093, A1201 (Ship Date 12/2013 17 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) 18 Serial Numbers A1022, A1044 (Ship Date 10/2013) 19 Serial Number A1059 (Ship Date 09/2013) 20 Serial Numbers A1021, A1060, A1062, A1063, A1065, A1066, A1067, A1069 (Ship Date 08/2013) - Amount recalled
- Total of 128 units
Where it was sold
- Nationwide
Why it was recalled
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).
This product could cause temporary or reversible health problems — stop using it.
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