CLASS II ONGOING Device recall · Reported 16 Mar 2022 · FDA Enforcement Report

NIM Trivantage EMG Endotracheal Tube recalled by Medtronic Xomed

Medtronic Xomed is recalling NIM Trivantage EMG Endotracheal Tube, distributed nationwide in the US. The recall was initiated on 22 Dec 2021 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesProducts: 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

Quantity recalled301,926 devices

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-0743-2022
FDA event ID: 89280
Recalling firm: Medtronic Xomed, Jacksonville, FL
Classification: Class II
Status: Ongoing
Recall initiated: 22 Dec 2021
FDA classified: 10 Mar 2022
Reported: 16 Mar 2022
Type: Voluntary: Firm initiated
Customers notified by: E-Mail
Reason category: Other Reasons
Device type: Other Medical Devices

Timeline

22 Dec 2021	Recall initiated by company
10 Mar 2022	Classified by FDA	+78 days
16 Mar 2022	Published in enforcement report	+6 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

There is potential for multiple issues due to a manufacturing nonconformity.

Product as listed by the FDA

NIM TRIVANTAGE EMG Endotracheal Tube

Where it was distributed

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.

Nationwide

Questions about this recall

Why was it recalled?

There is potential for multiple issues due to a manufacturing nonconformity.

Which lots are affected?

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

Where was it sold?

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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