Z-1044-2016Class II

Nebulizer Masks Opti-Mist and Opti-Mist Clear Nebulizer masks are intended to spray liquids in aerosol form...

Name: Z-1044-2016 Nebulizer Masks Opti-Mist and Opti-Mist Clear Nebulizer masks are intended to spray liquids in aerosol form...
Creator: ConvaTec, Inc
Published: 2015-11-11
License: https://open.fda.gov/license/

ConvaTec Limited / initiated 2015-11-11 / Terminated / root cause: manufacturing process

FDA source

ConvaTec, Inc began a recall of 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 on 2015-11-11. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1044-2016
Classification: Class II
Status: Terminated
Initiated: 2015-11-11
Posted: 2016-03-03
Terminated: 2016-07-18
Recalling firm: ConvaTec Limited
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 a patient.
Product code: LCQ Fluorescent Immunoassay Gentamicin
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.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: The firm, ConvaTec, sent each consignee affected by the recall an overnight express mail "Urgent Voluntary Recall Notice" and Response Form dated 12/7/2015. The notice described the product, problem and actions to be taken. The recall notice instructed the consignee to immediately stop distributing and quarantine all affected lots; perform a count of all recalled product currently in inventory; complete and return the enclosed Recall Response Form by email at [email protected] or by fax at 1-888-603-8986, and return all affected product, (ONLY return the lots affected with this recall). If you want replacement product contact customer service by phone at 1-800-634-6003, extension 1103 or by email at [email protected]. If you have any questions call 1-877-650-3492.
Quantity in commerce: 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.
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1044-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1044-2016	Class II	Terminated	Voluntary: Firm initiated	2016-03-09	2016-03-03

Product code LCQ

K801867Class IIDisposable Medication NebulizerHospitax / cleared 1980-08-20

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)