device · product 1 of 1
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 a patient.
- Recall number
- Z-1044-2016
- Initiated
- November 11, 2015
- Classification
- Class II
- Status
- Terminated
- Recalling firm
- ConvaTec, Inc
- Quantity
- 3,605,700 pieces
App-derived interpretation
The Nebulizer mask malfunctions in that there is reduced or no aerosol output. The malfunction occurs from the reduction in the diameter of a component part inside the nebulizer.
Official device-enrichment evidence · Sourced
Nonconforming Material/Component
Inspect official wording and provenance
Reason for recall
The Nebulizer mask malfunctions in that there is reduced or no aerosol output. The malfunction occurs from the reduction in the diameter of a component part inside the nebulizer.
Code information
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
Distribution pattern
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.