Stolen McGRATH MAC Video Laryngoscopes, REF: 301-000-000
This recall is currently active, issued November 2, 2023. It was issued by Covidien.
- Company
- Covidien
- Recall Initiated
- September 28, 2023
- Posted
- November 2, 2023
- Recall Number
- Z-0144-2024
- Quantity
- 5709
- Firm Location
- Boulder, CO
- Official Source
- View on FDA website ↗
Reason for Recall
Defective video laryngoscopes that did not pass quality tests established for the product, that were designated for destruction, were stolen, and subsequently distributed for sale. Defective device use may result in failed laryngoscopy and/or intubation.
Distribution
Unknown
Lot / Code Info
Stolen defective products are not appropriately packaged and labeled - Some are missing serial numbers. UDI-DI: 10884521776494, 20884521823393. Known Affected Serial Numbers: 000063, 000076, 000085, 000092, 000093, 000112, 000120, 000121, 000146, 000153, 000154, 000155, 000166, 000179, 000190, 000197, 000202, 000224, 000233, 000238, 000255, 000308, 000329, 000375, 000389, 000436, 000446, 000455, 000464, 000465, 000497, 000512, 000526, 000528, 000546, 000553, 000597, 000607, 000628, 000641, 000648, 000650, 000673, 000677, 000745, 000752, 000753, 000760, 000764, 000769, 000781, 000809, 000810, 000821, 000823, 000847, 000850, 000871, 000879, 000887, 000891, 000913, 000914, 000918, 000939, 000958, 000960, 001015, 001027, 001135, 001140, 001191, 001211, 001348, 001355, 001385, 001418, 001446, 001491, 001504, 001534, 001555, 001561, 001596, 001605, 001621, 001629, 001631, 001669, 001760, 001826, 001829, 001859, 001952, 001985, 002008, 002016, 002017, 002037, 002042, 002056, 002151, 002160, 002174, 002197, 002234, 002242, 002279, 002282, 002291, 002294, 002321, 002322, 002363, 002386, 002480, 002676, 002777, 002780, 002786, 002793, 002853, 002858, 002888, 002908, 002991, 003001, 003090, 003179, 003191, 003201, 003288, 003464, 003678, 003693, 003720, 003733, 003889, 003957, 004035, 004075, 004076, 004178, 004409, 004444, 004491, 004525, 004532, 004545, 004580, 004608, 004610, 004624, 004650, 004664, 004686, 004706, 004722, 004731, 004745, 004749, 004756, 004762, 004765, 004776, 004809, 004827, 004833, 004836, 004851, 004890, 004901, 004912, 004915, 004942, 004960, 004965, 004975, 004976, 100010, 100012, 100015, 100080, 100083, 100130, 100145, 100168, 100235, 100243, 100256, 100264, 100289, 100318, 100329, 100349, 100354, 100368, 100383, 100393, 100397, 100406, 100431, 100432, 100439, 100455, 100459, 100556, 100577, 100597, 100785, 100787, 100803, 100822, 100914, 101044, 101048, 101049, 101050, 101053, 101058, 101065, 101120, 101158, 101182, 101229, 101317, 101391, 101394, 101405, 101445, 101452, 101463, 101513, 101529, 101530, 101555, 101624, 101683, 101692, 101711, 101716, 101782, 101791, 101799, 101810, 101816, 101881, 101896, 101945, 101958, 101968, 101989, 101990, 101991, 101992, 101993, 101994, 101995, 101996, 101997, 101998, 101999, 102000, 102001, 102002, 102003, 102011, 102140, 102223, 102358, 102435, 102492, 102591, 102594, 102598, 102676, 102693, 102694, 102741, 102752, 102780, 102827, 102865, 102917, 102968, 102969, 103052, 103056, 103058, 103070, 103187, 103200, 103203, 103209, 103318, 103380, 103410, 103458, 103461, 103474, 103554, 103596, 103623, 103672, 103684, 103711, 103835, 103900, 103921, 104155, 104164, 104198, 104207, 104224, 104419, 104420, 104428, 104436, 104444, 104460, 104477, 104479, 104598, 104663, 104721, 104724, 104735, 104776, 104807, 104829, 104839, 104841, 104843, 104848, 104903, 104920, 104925, 104934, 104953, 104960, 104984, 104986, 105016, 105037, 105062, 105064, 105071, 105075, 105106, 105225, 105303, 105325, 105341, 105363, 105367, 105382, 105387, 105391, 105409, 105412, 105427, 105432, 105434, 105460, 105474, 105479, 105498, 105526, 105545, 105552, 105579, 105610, 105620, 105623, 105665, 105730, 105757, 105818, 105819, 105828, 105837, 105841, 105867, 105935, 105941, 105947, 105973, 106061, 106080, 106087, 106108, 106109, 106117, 106139, 106213, 106225, 106226, 106239, 106303, 106305, 106306, 106307, 106308, 106309, 106310, 106311, 106312, 106313, 106314, 106316, 106317, 106318, 106319, 106320, 106321, 106322, 106323, 106324, 106325, 106326, 106327, 106328, 106329, 106330, 106331, 106332, 106333, 106334, 106335, 106336, 106337, 106338, 106340, 106341, 106342, 106343, 106344, 106345, 106346, 106347, 106348, 106349, 106350, 106351, 106352, 106353, 106354, 106355, 106356, 106357, 106358, 106359, 106360, 106361, 106362, 106363, 106364, 106365, 106366, 106367, 106368, 106369, 106370, 106371, 106372, 106373, 106374, 106375, 106376, 106377, 106398, 106405, 106478, 106500, 106538, 106589, 106626, 106752.106760, 106762, 106773, 106883, 106889, 106976, 106986, 106992, 107037, 107216, 107277, 107281, 107384, 107414, 107461, 107468, 107488, 107507, 107534, 107548, 107549, 107550, 107553, 107612, 107613, 107623, 107671, 107705, 107706, 107743, 107873, 107902, 107908, 107911, 107914, 108021, 108044, 108062, 108080, 108090, 108142, 108175, 108191, 108209, 108283, 108301, 108304, 108323, 108348, 108377, 108390, 108422, 108481, 108550, 108562, 108585, 108588, 108598, 108617, 108663, 108672, 108746, 108827, 108871, 108898, 108901, 108966, 108971, 108980, 108981, 108997, 109035, 109051, 109066, 109080, 109081, 109085, 109088, 109155, 109201, 109211, 109367, 109457, 109483, 109506, 109558, 109563, 109571, 109655, 109662, 109707, 109718, 109730, 109773, 109791, 109913, 109984, 110066, 110102, 110135, 110167, 110170, 110173, 110176, 110178, 110181, 110203, 110206, 110293, 110301, 110303, 110332, 110337, 110338, 110359, 110369, 110409, 110433, 110435, 110466, 110531, 110564, 110643, 110670, 110749, 110828, 110837, 110911, 110921, 110925, 110926, 110930, 110950, 110951, 110966, 110967, 111003, 111023, 111064, 111097, 111219, 111243, 111292, 111298, 111318, 111364, 111366, 111384, 111417, 111453, 111498, 111503, 111508, 111516, 111576, 111581, 111660, 111708, 111719, 111800, 111814, 111819, 111838, 111867, 111885, 111914, 111937, 111940, 111943, 111954, 111957, 111962, 111988, 111998, 112000, 112013, 112027, 112054, 112059, 112084, 112088, 112093, 112096, 112114, 112117, 112124, 112141, 112145, 112146, 112180, 112182, 112188, 112190, 112195, 112199, 112210, 112221, 112245, 112256, 112289, 112295, 112341, 112374, 112376, 112382, 112384, 112385, 112388, 112439, 112502, 112534, 112610, 112619, 112639, 112694, 112700, 112718, 112737, 112757, 112760, 112786, 112822, 112826, 112834, 112846, 112847, 112850, 112894, 112909, 112916, 112920, 112922, 112934, 112941, 112974, 112984, 112989, 113007, 113009, 113032, 113065, 113081, 113082, 113115, 113120, 113145, 113155, 113167, 113181, 113201, 113206, 113222, 113237, 113240, 113258, 113263, 113265, 113267, 113271, 113274, 113302, 113330, 113344, 113388, 113403, 113454, 113474, 113487, 113517, 113520, 113528, 113543, 113563, 113588, 113604, 113620, 113660, 113704, 113705, 113810, 113814, 113822, 113837, 113886, 113891, 113897, 113898, 113899, 113904, 113912, 113922, 113923, 113953, 113979, 114013, 114149, 114161, 114176, 114185, 114201, 114204, 114210, 114228, 114245, 114275, 114277, 114281, 114284, 114289, 114293, 114296, 114298, 114302, 114306, 114309, 114311, 114319, 114327, 114334, 114338, 114343, 114346, 114354, 114357, 114389, 114397, 114400, 114402, 114413, 114434, 114440, 114458, 114470, 114480, 114485, 114518, 114526, 114550, 114655, 114659, 114662, 114663, 114677, 114691, 114732, 114786, 114787, 114789, 114841, 114842, 114844, 114857, 114861, 114867, 114870, 114872, 114873, 114880, 114904, 114910, 114949, 114951, 114960, 115000, 115002, 115072, 115077, 115087, 115158, 115227, 115237, 115240, 115260, 115280, 115291, 115338, 115356, 115358, 115403, 115410, 115446, 115454, 115467, 115476, 115521, 115530, 115595, 115620, 115677, 115691, 115737, 115744, 115779, 115812, 115819, 115820, 115825, 115875, 115897, 115911, 115933, 115935, 115939, 116048, 116098, 116111, 116120, 116147, 116207, 116309, 116311, 116337, 116349, 116409, 116415, 116463, 116496, 116513, 116515, 116522, 116524, 116526, 116538, 116553, 116581, 116604, 116631, 116640, 116732, 116752, 116754, 116811, 116831, 116835, 116837, 116842, 116944, 116957, 117013, 117030, 117073, 117099, 117107, 117120, 117123, 117148, 117176, 117192, 117200, 117209, 117263, 117272, 117295, 117312, 117346, 117373, 117376, 117417, 117433, 117437, 117478, 117555, 117589, 117627, 117628, 117645, 117657, 117659, 117677, 117687, 117697, 117705, 117707, 117734, 117765, 117774, 117786, 117794, 117804, 117835, 117851, 117873, 117890, 117896, 117930, 117937, 117992, 117993, 118003, 118011, 118041, 118045, 118054, 118057, 118168, 118180, 118187, 118213, 118222, 118229.118231, 118238, 118240, 118268, 118289, 118361, 118377, 118399, 118433, 118437, 118444, 118478, 118495, 118509, 118511, 118532, 118544, 118546, 118547, 118556, 118574, 118580, 118582, 118583, 118611, 118616, 118620, 118635, 118639, 118640, 118657, 118688, 118696, 118712, 118731, 118743, 118744, 118749, 118751, 118754, 118755, 118764, 118779, 118783, 118793, 118811, 118834, 118846, 118873, 118888, 118918, 118927, 118941, 118942, 118993, 119008, 119011, 119032, 119039, 119048, 119056, 119070, 119075, 119087, 119109, 119123, 119129, 119137, 119144, 119162, 119174, 119184, 119185, 119188, 119196, 119198, 119216, 119219, 119227, 119231, 119233, 119236, 119240, 119269, 119276, 119298, 119329, 119333, 119339, 119342, 119348, 119353, 119362, 119374, 119412, 119416, 119421, 119425, 119448, 119452, 119454, 119455, 119456, 119457, 119460, 119468, 119479, 119490, 119493, 119498, 119511, 119512, 119513, 119515, 119516, 119519, 119528, 119529, 119533, 119535, 119546, 119553, 119558, 119569, 119579, 119582, 119585, 119593, 119595, 119612, 119626, 119628, 119642, 119699, 119714, 119733, 119741, 119752, 119759, 119765, 119768, 119769, 119780, 119800, 119809, 119821, 119824, 119827, 119829, 119832, 119839, 119842, 119844, 119849, 119860, 119883, 119902, 119903, 119905, 119908, 119909, 119911, 119949, 119958, 119959, 119964, 119968, 119970, 119984, 120002, 120035, 120051, 120052, 120110, 120113, 120136, 120146, 120201, 120203, 120207, 120219, 120230, 120247, 120253, 120266, 120282, 120309, 120314, 120336, 120362, 120365, 120398, 120415, 120441, 120456, 120466, 120468, 120470, 120472, 120491, 120495, 120501, 120503, 120507, 120516, 120531, 120533, 120536, 120538, 120540, 120545, 120546, 120547, 120548, 120552, 120576, 120608, 120614, 120623, 120647, 120658, 120747, 120754, 120762, 120772, 120786, 120841, 120847, 120856, 120877, 120881, 120884, 120888, 120890, 120911, 120922, 120929, 120951, 120971, 120979, 120983, 120988, 120990, 120999, 121020, 121032, 121062, 121064, 121066, 121097, 121110, 121179, 121185, 121229, 121240, 121260, 121282, 121304, 121315, 121316, 121369, 121402, 121432, 121461, 121463, 121504, 121507, 121508, 121516, 121537, 121560, 121571, 121583, 121603, 121610, 121617, 121620, 121640, 121686, 121693, 121758, 121784, 121795, 121826, 121922, 121982, 121997, 122008, 122012, 122018, 122052, 122054, 122056, 122062, 122076, 122161, 122185, 122196, 122235, 122264, 122333, 122353, 122376, 122382, 122384, 122395, 122416, 122418, 122440, 122449, 122460, 122510, 122519, 122523, 122535, 122537, 122541, 122603, 122617, 122624, 122635, 122645, 122651, 122657, 122658, 122677, 122682, 122697, 122699, 122701, 122707, 122713, 122736, 122758, 122773, 122792, 122809, 122812, 122832, 122860, 122924, 122961, 122964, 122970, 122976, 122979, 122984, 122994, 123031, 123033, 123034, 123046, 123055, 123093, 123096, 123120, 123126, 123144, 123170, 123172, 123178, 123180, 123182, 123194, 123198, 123207, 123212, 123233, 123236, 123241, 123242, 123245, 123264, 123271, 123280, 123291, 123306, 123308, 123310, 123312, 123314, 123322, 123371, 123386, 123409, 123415, 123420, 123450, 123453, 123460, 123463, 123464, 123476, 123504, 123508, 123519, 123538, 123543, 123551, 123553, 123556, 123580, 123583, 123643, 123657, 123676, 123687, 123690, 123705, 123712, 123714, 123717, 123742, 123746, 123807, 123811, 123813, 123817, 123827, 123828, 123838, 123846, 123902, 123903, 123907, 123953, 123962, 123981, 123985, 123988, 123996, 124011, 124012, 124021, 124025, 124032, 124040, 124047, 124097, 124100, 124103, 124110, 124111, 124125, 124129, 124140, 124174, 124194, 124197, 124198, 124200, 124212, 124214, 124232, 124234, 124273, 124283, 124288, 124309, 124320, 124325, 124327, 124339, 124346, 124348, 124359, 124380, 124386, 124397, 124443, 124473, 124491, 124504, 124508, 124509, 124510, 124524, 124537, 124538, 124583, 124587, 124588, 124597, 124605, 124608, 124624, 124642, 124648, 124657, 124658, 124713, 124732, 124736, 124739, 124741, 124752, 124771, 124781, 124805, 124824.124845, 124848, 124861, 124890, 124891, 124901, 124925, 124933, 124939, 125006, 125021, 125026, 125082, 125085, 125092, 125110, 125129, 125137, 125142, 125147, 125154, 125176, 125183, 125184, 125205, 125232, 125237, 125256, 125284, 125287, 125306, 125319, 125347, 125352, 125371, 125401, 125402, 125404, 125417, 125427, 125451, 125465, 125482, 125488, 125489, 125491, 125492, 125496, 125501, 125504, 125512, 125527, 125529, 125530, 125533, 125543, 125567, 125572, 125574, 125582, 125583, 125589, 125605, 125613, 125633, 125634, 125637, 125654, 125674, 125685, 125688, 125696, 125734, 125738, 125742, 125743, 125781, 125790, 125796, 125798, 125808, 125817, 125818, 125824, 125835, 125857, 125899, 125900, 125908, 125913, 125916, 125924, 125928, 125937, 126017, 126019, 126023, 126026, 126034, 126061, 126065, 126066, 126087, 126115, 126134, 126185, 126235, 126238, 126246, 126267, 126269, 126272, 126281, 126287, 126291, 126300, 126303, 126305, 126325, 126329, 126348, 126356, 126371, 126372, 126401, 126414, 126453, 126513, 126517, 126654, 126685, 126742, 126749, 126751, 126756, 126758, 126763, 126765, 126774, 126783, 126790, 126792, 126793, 126890, 126897, 126906, 126909, 126926, 126930, 126970, 127008, 127164, 127223, 127329, 127424, 127719, 127731, 128644, 128693, 129220, 129278, 129283, 129284, 129294, 129328, 130120, 130121, 130424, 130425, 130426, 130427, 130435, 130461, 130462
Root Cause
Process control
Action Taken
On 9/28/23, Medtronic posted a news release on their website entitled Medtronic Notification of Stolen Defective Products - Potentially Defective McGRATH MAC Video Laryngoscopes. These affected products are defective and should not be used. Firm urges healthcare professionals to purchase products only from trusted and reliable sources, such as directly from Medtronic or its authorized distributors. To find an authorized distributor or to purchase directly from Medtronic, contact Customer Service at 800-962-9888, Option 2. The stolen defective products are not appropriately packaged and labeled. See the news release for images of conforming devices: https://news.medtronic.com/Medtronic-Notification-of-Stolen-Defective-Products-Potentially-Defective-McGRATH-TM-MAC-Video-Laryngoscopes Anyone with information regarding the promotion or sale of potentially stolen products are encouraged to contact Medtronic Customer Service at 800-962-9888, Monday through Friday from 8AM to 7PM ET.