Nebulizer Masks Opti-Mist and Opti-Mist Clear Nebulizer recall

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

lot/batch numbers 13-23, 13-24, 13-29, 13-30, 13-31, 13-32, 97750, 97774, 97777, 97870, 97871, 97873, 97874, 97880, 97988, 98030, 98031, 98033, 98034, 98043, 98048, 98058, 98059, 98099, 98103, 98330, 98338, 98380, 98491, 98520, 98546, 98556, 98570, 98571, 98578, 98595, 98635, 98683, 98694, 98721, 98722, 98730, 98733, 98738, 98777, 98779, 98782, 98840, 98841, 98843, 98844, 98853, 98856, 98859, 98867, 98868, 98869, 98870, 98871, 98969, 99078, 99079, 99199, 99206, 99207, 99227, 99230, 99231, 99232, 99297, 99397, 99398, 99447, 99450, 99451, 99466, 99492, 99539, 99577, 99578, 99591, 99606, 99628, 99630, 99631, 99642, 99661, 99673, 99674, 99708, 99709, 99735, 99845, 99852, 99853, 99854, 99919, 99920, 99928, 99932, 99997, 100029, 100065, 100066, 100074, 100077, 100101, 100102, 100114, 100119, 100155, 100167, 100177, 100180, 100205, 100206, 100207, 100238, 100254, 100401, 100402, 100424, 100483, 100506, 100516, 100546, 100549, 100552, 100563, 100599, 100603, 100693, 100697, 100700, 100705, 100752, 100759, 100784, 100809, 100812, 100814, 100871, 100931, 100984, 100985, 101186, 101200, 101201, 101202, 101310, 101312, 101450, 101473, 101474, 101484, 101485, 101527, 101528, 101533, 101537, 101555, 101556, 101557, 101558, 101559, 101625, 101626, 101686, 101704, 101708, 101709, 101721, 101723, 101750, 101751, 101752, 101753, 101759, 101761, 101785, 101889, 109211, 101926, 101949, 101984, 102038, 102046, 102061, 102063, 102076, 102135, 102138, 102141, 102281, 102284, 102330, 102389, 102461, 102468, 102473, 102474, 102476, 102478, 102570, 102571, 102606, 102642, 102671, 102681, 102702, 102703, 102710, 102712, 102720, 102725, 102744, 102745, 102746, 102751, 102796, 102806, 102807, 102861, 102945, 102976, 103021, 103076, 103079, 103116, 103151, 103161, 103166, 103206, 103284, 103301, 103341, 103342, 103348, 103387, 103429, 103431, 103432, 103448, 103449, 103463, 103464, 103465, 103485, 103575, 103580, 103585, 103587, 103607, 103674, 103675, 103693, 103694, 103695, 103746, 103747, 103786, 103790, 103802, 103803, 103825, 103827, 103829, 103857, 103890, 103892, 103917, 103928, 103979, 103980, 104005, 104011, 104043, 104046, 104055, 104067, 104068, 104092, 104093, 104095, 104096, 104100, 104101, 104110, 104131, 104211, 104220, 104222, 104223, 104224, 104225, 104243, 104244, 104245, 104254, 104274, 104333, 104335, 104415, 104442, 104449, 104451, 104464, 104484, 104503, 104509, 104510, 104514, 104598, 194601, 104628, 104647, 104750, 104753, 104756, 104783, 104818, 104820, 104830, 104831, 104867, 104916, 104945, 105002, 105003, 105012, 105013, 105014, 105015, 105016, 105017, 105018, 105021, 105022, 105023, 105025, 105026, 105137, 105179, 105195, 105238, 105242, 105243, 105318, 105327, 105328, 105334, 105361, 105362, 105363, 105397, 105414, 105415, 105420, 105423, 105452, 105467, 105509, 105513, 105573, 105593, 105680, 105693, 105699, 105702, 105703, 105704, 105728, 105729, 105730, 105731, 105736, 105767, 105772, 105795, 105827, 105833, 105835, 105836, 105849, 105852, 105853, 105906, 105960, 105961, 105980, 105989, 106022, 106023, 106024, 106114, 106153, 106154, 106155, 106156, 106174, 106189, 106250, 106263, 106275, 105286, 106286, 106308, 106337, 106338, 106347, 106357, 106381, 106382, 106385, 106386, 106436, 106456, 106490, 106514, 106521, 106523, 106532, 106596, 106571, 106612, 106657, 106658, 106744, 106745, 106755, 106766, 106782, 106785, 106806, 106842, 106977, 106978, 106982, 106998, 107123, 107124, 107147, 107174, 107220, 107223, 107304, 107309, 107372, 107401, 107468, 107502, 107516, 107544, 107592, 107610, 107631, 107657, 107717, 107739, 107751, 107757, 107826, 107844, 107845, 107872, 107886, 107896, 107969, 107972, 107973, 107974, 108057, 108144, 108223, 108225, 108421, 108422, 108423, 108424, 108425, 108427, 108432, 108451, 108453, 108460, 108461, 108462, 108469, 108470, 108471, 108472, 108473, 108476, 108477, 108478, 108501, 108502, 108503, 108550, 108551, 108600, 108601, 108615, 108653, 108655, 108662, 108663, 108677, 108709, 108712, 108714, 108721, 108725, 108726, 108730, 108734, 108741, 108747, 108815, 108820, 108892, 108893, 108894, 108906, 108908, 108920, 108926, 108928, 108940, 108946, 108951, 108956, 108966, 108968, 108970, 108982, 108988, 109058, 109082, 109092, 109096, 109113, 109130, 109162, 109205, 109206, 109211, 109420, 109222, 109223, 109225, 109226, 109227, 109245, 109301, 109345, 109377, 109403, 109417, 109421, 109437, 109462, 109552, 109555, 109559, 109581, 109690, 109694, 109718, 109719, 109739, 109746, 109763, 109805, 109885, 109969, 109972, 109985, 109994, 110026, 110329, 110557, 111011, 111041, 111042, 111468, 111469, 111470, 111971, 112005, 112062

Product

Nebulizer Masks Opti-Mist and Opti-Mist Clear Nebulizer masks are intended to spray liquids in aerosol form into gasses that are delivered directly to…

Recalling firm

ConvaTec, Inc

Quantity

3,605,700 pieces

Distribution

Worldwide Distribution: US (nationwide) including states of: AL, AZ, AR, CA, CO, CT, FL, GA, IL, IN, IA, KS, ME, MA, MN, MS, MO, NV, NH, NJ, NY, NC, OH, OR, PA, SC, TX VA, WA, WI, and countries of: Australia, Belgium, Burma, Canada, Denmark, Egypt, Estonia, Faroe Islands, Finland, France, Germany, Israel, Italy, Jordan, Kenya, Kuwait, Netherlands, Norway, Russia, Saudi Arabia, Sweden, Switzerland, United Kingdom & Vietnam.

Recall date

March 9, 2016

Classification

Class II

Status

Terminated

Agency

FDA (device)