NIM TRIVANTAGE EMG Endotracheal Tube
- Company
- Medtronic Xomed, Inc.
- Recall Initiated
- December 22, 2021
- Recall Number
- Z-0743-2022
- Quantity
- 301,926 devices
- Firm Location
- Jacksonville, FL
Reason for Recall
There is potential for multiple issues due to a manufacturing nonconformity.
Distribution
Worldwide distribution - US Nationwide and the countries of Algeria, Argentina, Australia, Austria, Bahrain, Bangladesh, Belgium, Brazil, Canada, Canary Islands, Chile, China, Colombia, Costa Rica, Croatia, Cyprus, Czech Republic, Denmark, Dominican Republic, Faroe Islands, Finland, France, French Guinea, Germany, Greece, Guadeloupe, Guam, Guatemala, Hong Kong, Hungary, Iceland, India, Ireland, Israel, Italy, Japan, Korea (Republic of), Kuwait, Lebanon, Libya, Luxembourg, Malaysia, Mauritius, Mayotte, Mexico, Morocco, Namibia, Netherlands, New Caledonia, New Zealand, North Macedonia, Norway, Panama, Philippines, Poland, Portugal, Qatar, Reunion, Romania, Russia, Saudi Arabia, Serbia, Singapore, Slovakia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, United Arab Emirates, United Kingdom, and Vietnam.
Lot / Code Info
Products: 1) Product Number 8229705 (GTIN 00763000033934); Lots: 0218762694, 0218663943, 0219904500, 0220293429, 0220584798, 0220756285, 0220774358, 0221736070, 0221805033, 0222186741, 0222495993, 0222591367 2) Product Number 8229706 (GTIN 00763000033941); Lots: 0218663944, 0218664146, 0218762695, 0218762699, 0218762698, 0218762697, 0219010138, 0219010139, 0219010142, 0219010140, 0219010141, 0219278186, 0219272545, 0219278189, 0219278188, 0219278190, 0219444156, 0219444157, 0219278187, 0219444160, 0219444158, 0219444159, 0219444161, 0219836614, 0219972527, 0219969085, 0219972526, 0219972528, 0219836616, 0220087597, 0220087596, 0220087598, 0220293430, 0220293432, 0220293434, 0220293431, 0220293433, 0220293435, 0220371534, 0220371535, 0220371537, 0220371536, 0220517619, 0220517618, 0220584803, 0220584804, 0220734720, 0220769468, 0220769470, 0220878556, 0220769469, 0220878557, 0220934885, 0221123594, 0221123639, 0221248868, 0221248867, 0221248869, 0221493241, 0221543453, 0221543452, 0221637121, 0221637122, 0221710524, 0221805030, 0221805031, 0221805039, 0221805041, 0222048142, 0222024594, 0222057391, 0222140123, 0222200982, 0222200983, 0222200984, 0222239875, 0222239874, 0222352848, 0222396630, 0222428754, 0222465659, 0222495994, 0222495995, 0222495996, 0222542347, 0222542348, 0222563000, 0222563288, 0222738659, 0222719941, 0222684388 3) Product Number 8229707 (GTIN 00763000033958); Lots: 0218664151, 0218664148, 0218664149, 0218664157, 0218664156, 0218664155, 0218664150, 0218664154, 0218664158, 0218664153, 0218664152, 0218762700, 0218762705, 0218762701, 0218762704, 0218762703, 0218762806, 0218762702, 0218762807, 0218762812, 0218762809, 0218762814, 0218762815, 0219010143, 0219010144, 0219010145, 0219010806, 0219010807, 0219010809, 0219010813, 0219010811, 0219010810, 0219010808, 0219010812, 0219010814, 0219010816, 0219010818, 0219010819, 0219010817, 0219010820, 0219010815, 0219010821, 0219010822, 0219278191, 0219444374, 0219444375, 0219444376, 0219278193, 0219278196, 0219278195, 0219278192, 0219278197, 0219278194, 0219444369, 0219444370, 0219278198, 0219444371, 0219952959, 0219444372, 0219985176, 0219444373, 0219985177, 0219723502, 0219952958, 0220033883, 0220033885, 0220037915, 0220047459, 0220047460, 0220057008, 0220057009, 0220057010, 0220057011, 0220076607, 0220081032, 0220081037, 0220008824, 0220008823, 0220010546, 0220010547, 0220008825, 0220010548, 0220087591, 0220087602, 0220087599, 0220087601, 0220087600, 0220087603, 0220142052, 0220087886, 0220142053, 0220142054, 0220142055, 0220142060, 0220149776, 0220149778, 0220230467, 0220230468, 0220230472, 0220230469, 0220142057, 0220142058, 0220142059, 0220149779, 0220142063, 0220142064, 0220142062, 0220142065, 0220370784, 0220370785, 0220371526, 0220371528, 0220371527, 0220371530, 0220371529, 0220371531, 0220371532, 0220371533, 0220517189, 0220517190, 0220517620, 0220517621, 0220517191, 0220517193, 0220517194, 0220517192, 0220517195, 0220517196, 0220517197, 0220517199, 0220517200, 0220517198, 0220517201, 0220517202, 0220622252, 0220622253, 0220637407, 0220637408, 0220637409, 0220637410, 0220688264, 0220688265, 0220691509, 0220691510, 0220734718, 0220756281, 0220756282, 0220756283, 0220756284, 0220769471, 0220804919, 0220769472, 0220798476, 0220813969, 0220813970, 0220817687, 0220817686, 0220826216, 0220826217, 0220845825, 0220846126, 0220857889, 0220878558, 0220878559, 0220878561, 0220878560, 0220878562, 0220878563, 0220913062, 0220935486, 0220935487, 0220935488, 0220935489, 0220974382, 0221040035, 0221056071, 0221040036, 0221056072, 0221082044, 0221069155, 0221082126, 0221073627, 0221090328, 0221090327, 0221097604, 0221097605, 0221098067, 0221098066, 0221118571, 0221118572, 0221123591, 0221123638, 0221146333, 0221146457, 0221146458, 0221146460, 0221146459, 0221146461, 0221146462, 0221146463, 0221146879, 0221146889, 0221146901, 0221248875, 0221248876, 0221248877, 0221248878, 0221248879, 0221248880, 0221248881, 0221248882, 0221248883, 0221248884, 0221248885, 0221378722, 0221378724, 0221378725, 0221379386, 0221379387, 0221379388, 0221493665, 0221493866, 0221514981, 0221526915, 0221526917, 0221526918, 0221526920, 0221526919, 0221571421, 0221599118, 0221599117, 0221599181, 0221599119, 0221651974, 0221637118, 0221656119, 0221656118, 0221659143, 0221659144, 0221736003, 0221736005, 0221766209, 0221766208, 0221766211, 0221736786, 0221805043, 0221772984, 0221886337, 0221805044, 0221893434, 0221893435, 0221897719, 0221897720, 0221893433, 0221924396, 0221931540, 0221938902, 0221938901, 0221962166, 0221967955, 0222057392, 0222024589, 0222069694, 0222093329, 0222069692, 0222069693, 0222093330, 0222101075, 0222110921, 0222110922, 0222136940, 0222106107, 0222139599, 0222139600, 0222140118, 0222140119, 0222140125, 0222140446, 0222163047, 0222140120, 0222168488, 0222168489, 0222168491, 0222168492, 0222168493, 0222202227, 0222202226, 0222202228, 0222202230, 0222202231, 0222239881, 0222202232, 0222239878, 0222239882, 0222239883, 0222239884, 0222240046, 0222240047, 0222239885, 0222202229, 0222312293, 0222312878, 0222334222, 0222334223, 0222334220, 0222334221, 0222358414, 0222334224, 0222358415, 0222358416, 0222358417, 0222358418, 0222396631, 0222396632, 0222396634, 0222396633, 0222396635, 0222456848, 0222456849, 0222456850, 0222456851, 0222456852, 0222476127, 0222476128, 0222476130, 0222476131, 0222476129, 0222495997, 0222495998, 0222495999, 0222496000, 0222496001, 0222496002, 0222496003, 0222542350, 0222542349, 0222542352, 0222542351, 0222542353, 0222563004, 0222563286, 0222684391, 0222684395, 0222684394, 0222738663, 0222738660, 0222738661, 0222563287, 0222719938, 0222719943, 0222720028, 0222719945, 0222563002, 0222684393, 0222738665, 0222738664, 0222720029, 0222684392, 0222563001, 0222563005, 0222857893, 0222563003, 0222857891, 0222857894, 0222857892, 0222857896, 0222857895, 0222857897, 0222857898, 0222857900, 0222738662, 0222719944 4) Product Number 8229708 (GTIN 00763000033965); Lots: 0218664160, 0218664159, 0218664163, 0218664161, 0218664162, 0218762816, 0218762821, 0218762820, 0218762818, 0218762819, 0218762822, 0219278200, 0219278201, 0219278199, 0219278202, 0219444162, 0219444163, 0219444165, 0219444164, 0220087592, 0220087593, 0220087594, 0220087595, 0220142108, 0220142106, 0220142109, 0220293438, 0220293439, 0220228325, 0220142110, 0220293440, 0220517617, 0220517616, 0220658898, 0220517614, 0220517615, 0220370781, 0220142111, 0220730554, 0220370782, 0220370783, 0220855164, 0220855449, 0220855447, 0220873204, 0220855448, 0220935503, 0220935651, 0220935648, 0220935505, 0220935654, 0221056080, 0221056081, 0221097602, 0221097603, 0221146446, 0221146343, 0221146448, 0221146951, 0221146936, 0221248874, 0221378720, 0221588082, 0221588083, 0221637123, 0221710525, 0221710926, 0221851581, 0221851580, 0221893436, 0221931647, 0221931648, 0222031317, 0222081991, 0222101073, 0222140122, 0222140121, 0222217071, 0222240048, 0222302776, 0222358419, 0222358421, 0222396636, 0222396637, 0222456853, 0222456854, 0222476133, 0222542354, 0222563290, 0222720030, 0222739006 5) Product Number 8229709 (GTIN 00763000033972); Lots: 0222248291, 0218452814, 0218540733, 0218540734, 0218540735, 0218452815, 0218515807, 0218275886, 0218275305, 0218496850, 0219906760, 0220586086, 0220973095, 0221248873, 0221517237, 0221805028, 0222187092, 0222336506 6) Product Number 8229735 (GTIN 20763000041506); Lots: 0218275302, 0220584797, 0220883592, 0221996821, 0222146974 7) Product Number 8229736 (GTIN 20763000041513); Lots: 0221246105, 0218762830, 0218762829, 0219010518, 0219010517, 0219010516, 0219904499, 0219985174, 0220293436, 0220293437, 0220584799, 0220880266, 0220998690, 0221038763, 0221248866, 0221378719, 0221543451, 0221805267, 0222024592, 0222140124, 0222240053, 0222527962, 0222684399 8) Product Number 8229737 (GTIN 20763000041520); Lots: 0222908102, 0218762831, 0218762833, 0218762832, 0218762835, 0218762834, 0219010519, 0219733959, 0219744709, 0219788607, 0219785665, 0219795301, 0219788608, 0219795296, 0219795302, 0219795303, 0219802959, 0219802960, 0219836612, 0219836613, 0219904496, 0219904497, 0219972534, 0219972535, 0219972536, 0219972537, 0219985178, 0219972538, 0219802958, 0220010550, 0220010551, 0220010554, 0220010552, 0220010555, 0220087604, 0220087605, 0220142112, 0220142116, 0220142113, 0220142114, 0220230480, 0220228945, 0220230481, 0220230426, 0220230427, 0220230428, 0220230429, 0220230430, 0220293443, 0220293444, 0220293442, 0220713083, 0220734719, 0220734721, 0220769475, 0220769474, 0220769476, 0220785122, 0220790899, 0220826214, 0220847263, 0220826215, 0220857890, 0221010990, 0220998691, 0221034442, 0221035008, 0221038764, 0221056079, 0221248870, 0221248871, 0221248872, 0221378718, 0221463272, 0221463273, 0221493867, 0221493869, 0221493238, 0221493240, 0221543449, 0221637119, 0221637120, 0221718467, 0221766210, 0221805034, 0221805035, 0221805037, 0221805038, 0221924395, 0221910040, 0221967715, 0221931646, 0222024596, 0222024590, 0222024595, 0222034111, 0222034109, 0222065770, 0222119577, 0222123196, 0222187098, 0222334225, 0222358420, 0222396638, 0222456855, 0222496004, 0222496005, 0222739007, 0222563291, 0222684396, 0222719939, 0222720026, 0222739008, 0222562999, 0222542355, 0010791039 9) Product Number 8229738 (GTIN 20763000041537); Lots: 0218762837, 0218762838, 0218762840, 0218762842, 0218762841, 0219011550, 0219011551, 0219011552, 0219861141, 0219878783, 0219861136, 0219878782, 0219878784, 0219879026, 0219952951, 0219952952, 0220142117, 0220142118, 0220142119, 0220142120, 0220142121, 0220855453, 0220966544, 0221038762, 0221146339, 0221247365, 0221463276, 0221514982, 0221543448, 0221765700, 0221898348, 0222007804, 0222031318, 0222187101, 0222476134, 0222739009, 0222542356, 0222684398 10) Product Number 8229739 (GTIN 20763000041544); Lots: 0218762824, 0220584805, 0222024591, 0222272928, 0222476135
Root Cause
Process control
Action Taken
Medtronic will distribute a removal notice to impacted U.S. consignees, on 22-Dec-2021. A second attempt to notify US consignees is scheduled for the week of 02-Feb-2022. A third attempt to notify US consignees is scheduled for the week of 16-Mar-2022. Consignees are asked to take the following actions immediately: 1) Do NOT use any impacted product. Remove and quarantine all unused impacted product(s) in your inventory. 2) Return the impacted product(s) to Medtronic. Your Medtronic representative can assist in facilitating the return of the product as necessary. If an alternative product is needed, your Medtronic representative can assist you with identifying a suitable replacement product. 3) Complete the attached Customer Confirmation Form, and fax it to Medtronic at 800-897-3899 or 651-367-0814 to the attention of the FCA Execution Team or email it to neuro.quality@medtronic.com Consignees are asked to share the communication within their organization and with other organizations where impacted devices have been transferred, and any other associated organizations that may be impacted by this action.