510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
Z-0743-2022Class II

NIM TRIVANTAGE EMG Endotracheal Tube

Medtronic Xomed, Inc. / initiated 2021-12-22 / Open, Classified / root cause: manufacturing process
FDA source (opens on fda.gov)

Medtronic Xomed, Inc. began a recall of NIM TRIVANTAGE EMG Endotracheal Tube on . FDA classified it as Class II and gives the reason as "There is potential for multiple issues due to a manufacturing nonconformity". As of , the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number
Z-0743-2022
Classification
Class II
Status
Open, Classified
Initiated
Posted
Recalling firm
Medtronic Xomed, Inc.
Product
NIM TRIVANTAGE EMG Endotracheal Tube
Product code
ETN Stimulator, Nerve
Reason for recall
There is potential for multiple issues due to a manufacturing nonconformity.
Root cause tag
manufacturing process
FDA root cause
Process control
Action
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 [email protected] 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.
Quantity in commerce
301,926 devices
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.
Product codes and lots
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

Enforcement reports

One row per recalled product line
FDA enforcement reports joined to recall event Z-0743-2022
Recall numberClassStatusVoluntary or mandatedReport dateClassified
Z-0743-2022Class IIOngoingVoluntary: Firm initiated