Stolen McGRATH MAC Video Laryngoscopes, REF: 301-000-000
Covidien began a recall of Stolen McGRATH MAC Video Laryngoscopes, REF: 301-000-000 on . FDA classified it as Class I and gives the reason as "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...". As of , the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.
Recall record
- Recall number
- Z-0144-2024
- Classification
- Class I
- Status
- Open, Classified
- Initiated
- Posted
- Recalling firm
- Medtronic, Inc.
- Product
- Stolen McGRATH MAC Video Laryngoscopes, REF: 301-000-000
- Product code
- CCW Laryngoscope, Rigid
- 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.
- Root cause tag
- manufacturing process
- FDA root cause
- Process control
- Action
- 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.
- Quantity in commerce
- 5709
- Distribution
- Unknown
- Product codes and lots
- 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
Enforcement reports
One row per recalled product line| Recall number | Class | Status | Voluntary or mandated | Report date | Classified |
|---|---|---|---|---|---|
| Z-0144-2024 | Class I | Ongoing | Voluntary: Firm initiated |
FIRST ARTICLE / WEEKLY
What cleared, what was recalled, and what changed in the standards. One edition a week for the people who make medical devices.
