Class 2 Device Recall Nebulizer Mask

• Date Initiated by Firm: November 11, 2015
• Date Posted: March 03, 2016
• Recall Status: Terminated on July 18, 2016
• Recall Number: Z-1044-2016
• Recall Event ID: 72823
• 510(K)Number: K801867
• Product Classification: Fluorescent immunoassay gentamicin - Product Code LCQ
• 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.
• 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
• Recalling Firm/ Manufacturer: ConvaTec, Inc; 7900 Triad Center Dr Ste 400; Greensboro NC 27409-9076
• For Additional Information Contact: Robert A. Steele; 336-297-3086
• Manufacturer 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.
• FDA Determined 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 convatec3657@stericyle.com 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 respiratoryorders@convatec.com. 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.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = LCQ and Original Applicant = HOSPITAX