Events

Recall of Device Recall Nebulizer Mask

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by ConvaTec, Inc.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    72823
  • Event Risk Class
    Class 2
  • Event Number
    Z-1044-2016
  • Event Initiated Date
    2015-11-11
  • Event Date Posted
    2016-03-03
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2016-07-18
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=142303
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Fluorescent immunoassay gentamicin - Product Code LCQ
  • Reason
    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.
  • 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.

Device

Device Recall Nebulizer Mask
  • Model / Serial
    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 Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    2
  • Implanted device?
    No
  • 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 Description
    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.
  • Manufacturer
    ConvaTec, Inc

Manufacturer

ConvaTec, Inc
  • Manufacturer Address
    ConvaTec, Inc, 7900 Triad Center Dr Ste 400, Greensboro NC 27409-9076
  • Manufacturer Parent Company (2017)
    Triona Holding Sa
  • Source
    USFDA