Recall archive / FDA device enforcement

a) PEDIATRIC TRACHEOSTOMY TUBE 2.5mm TTS FLEXTEND STRAIGHT NECK , Product Code/List Number/Item Code 67PFSS25; b) PED... — FDA record Z-2614-2024

Reported ongoing

Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.

Source date May 29, 2024. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.

Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.

What the record says

Product: a) PEDIATRIC TRACHEOSTOMY TUBE 2.5mm TTS FLEXTEND STRAIGHT NECK , Product Code/List Number/Item Code 67PFSS25; b) PEDIATRIC TRACHEOSTOMY TUBE 3.0mm TTS FLEXTEND STRAIGHT NECK , Product Code/List Number/Item Code 67PFSS30; c) PEDIATRIC TRACHEOSTOMY TUBE 3.5mm TTS FLEXTEND STRAIGHT NECK , Product Code/List Number/Item Code 67PFSS35; d) PEDIATRIC TRACHEOSTOMY TUBE 4.0mm TTS FLEXTEND STRAIGHT NECK , Product Code/List Number/Item Code 67PFSS40; e) PEDIATRIC TRACHEOSTOMY TUBE 4.5mm TTS FLEXTEND STRAIGHT NECK , Product Code/List Number/Item Code 67PFSS45; f) PEDIATRIC TRACHEOSTOMY TUBE 5.0mm TTS FLEXTEND STRAIGHT NECK , Product Code/List Number/Item Code 67PFSS50; g) PEDIATRIC TRACHEOSTOMY TUBE 5.5mm TTS FLEXTEND STRAIGHT NECK , Product Code/List Number/Item Code 67PFSS55
Reason: Smiths Medical has identified that the securement flange of specific lots of the Bivona Neonatal/Pediatric and Adult Tracheostomy products may tear because of a manufacturing defect.
Classification: Class I
Recalling firm: Smiths Medical ASD Inc.
Quantity: Not supplied
Agency-reported status: Ongoing
Source record identifier: Z-2614-2024

Open the official record

What the recall classes mean. Classification is an agency assessment, not individual medical advice.

Lot and product identifiers

Label field	Details supplied by the agency
Lot, code or applicability	a) UDI/DI 10351688518668, Product Code/List Number/Item Code 67PFSS25, Lot Numbers: 3897874, 3911416, 3923743, 4005596, 4016053, 4016057, 4080314, 4087038, 4217435, 4327880, 4334932, 4374412, 4381000; b) UDI/DI 10351688518675, Product Code/List Number/Item Code 67PFSS30, Lot Numbers: 3853409, 3853410, 3868326, 3871053, 3877650, 3887740, 3897845, 3923723, 3931154, 3939667, 3939668, 3946281, 3959294, 3961757, 3961758, 3981997, 3981998, 3987959, 3991133, 4005597, 4011365, 4035710, 4051637, 4051638, 4063173, 4071984, 4075246, 4089295, 4095916, 4096830, 4110438, 4116085, 4136131, 4138990, 4156656, 4159994, 4171580, 4171581, 4185411, 4195802, 4212764, 4217436, 4233952, 4254222, 4273418, 4276453, 4276454, 4279325, 4292159, 4322660, 4322661, 4327910, 4329839, 4334936, 4344353, 4344980, 4344981, 4348422, 4357249, 4357250, 4358491, 4358492, 4374413, 4380076, 4381001, 4383608, 4388128, 4388129, 4388130, 4389879, 4393395, 4395763, 4399143; c) UDI/DI 10351688518682, Product Code/List Number/Item Code 67PFSS35, Lot Numbers: 3835792, 3835793, 3853413, 3853414, 3858170, 3868261, 3868262, 3868263, 3868264, 3868265, 3868266, 3871041, 3871042, 3874323, 3880694, 3884245, 3884246, 3887727, 3891518, 3891519, 3894917, 3897876, 3901297, 3904685, 3911418, 3911419, 3917989, 3920964, 3923741, 3923742, 3930045, 3930046, 3933473, 3939641, 3939642, 3939643, 3939644, 3939645, 3942544, 3942545, 3942546, 3946257, 3946258, 3946259, 3946260, 3946261, 3946262, 3955809, 3955810, 3959312, 3959313, 3959314, 3962594, 3965924, 3965925, 3981999, 3982000, 3987962, 3987965, 3987984, 3991134, 4005598, 4005599, 4005605, 4005606, 4008203, 4008204, 4011366, 4011367, 4018508, 4018509, 4021421, 4023783, 4029500, 4033710, 4033711, 4035711, 4035712, 4035713, 4041963, 4043943, 4048012, 4051666, 4051667, 4053727, 4056245, 4056246, 4063174, 4066300, 4066301, 4067718, 4067719, 4067720, 4070846, 4075247, 4077104, 4077105, 4080787, 4080788, 4083925, 4086026, 4091405, 4091406, 4096848, 4097831, 4100900, 4107609, 4110439, 4116102, 4116122, 4119107, 4122428, 4125807, 4128028, 4131000, 4134036, 4134037, 4136129, 4139027, 4142442, 4142455, 4148021, 4148022, 4151058, 4151059, 4153585, 4156639, 4159984, 4163841, 4163843, 4168162, 4176243, 4176244, 4176246, 4176247, 4176248, 4179345, 4195803, 4196263, 4196264, 4196265, 4197606, 4201337, 4201338, 4201339, 4204806, 4212765, 4213412, 4216312, 4216313, 4216314, 4217437, 4218698, 4218699, 4231487, 4233953, 4237362, 4237363, 4237364, 4237365, 4237366, 4237367, 4240132, 4240133, 4247286, 4254223, 4254224, 4260059, 4260060, 4267840, 4267841, 4267842, 4273419, 4273420, 4276455, 4276456, 4279326, 4283224, 4283225, 4283226, 4283227, 4289470, 4289471, 4322662, 4322663, 4327911, 4328219, 4329825, 4329831, 4329836, 4334941, 4334942, 4334943, 4334944, 4334945, 4334946, 4334970, 4334973, 4344982, 4344983, 4344984, 4344985, 4351224, 4351225, 4352774, 4360417, 4360418, 4365787, 4369573, 4369574, 4369575, 4374414, 4374415, 4374416, 4374417, 4381002, 4381003, 4381004, 4381005, 4381006, 4383609, 4383610, 4383611, 4383612, 4388131, 4388132, 4388133, 4388134, 4388135, 4389880, 4389881, 4389882, 4389883, 4389884, 4393397; d) UDI/DI 10351688518699, Product Code/List Number/Item Code 67PFSS40, Lot Numbers: 3840066, 3853416, 3853417, 3853418, 3853419, 3853420, 3853421, 3868249, 3868250, 3868251, 3868252, 3874298, 3874299, 3877664, 3880692, 3884236, 3887724, 3891537, 3891538, 3894875, 3894876, 3901281, 3901282, 3904661, 3911426, 3911427, 3923728, 3930019, 3930020, 3933474, 3936585, 3939685, 3939686, 3939687, 3939688, 3942513, 3942514, 3942515, 3946293, 3946294, 3946295, 3946296, 3946297, 3946298, 3955756, 3955757, 3955758, 3962582, 3962583, 3962584, 3965918, 3982004, 3982005, 3982007, 3985840, 3985841, 3987966, 3987971, 3991135, 4005610, 4005611, 4005612, 4005614, 4008205, 4008206, 4011368, 4011370, 4015533, 4015534, 4018510, 4018511, 4021417, 4023784, 4026687, 4033713, 4033714, 4035715, 4035716, 4035717, 4040573, 4041965, 4048032, 4048033, 4051620, 4051621, 4053706, 4053707, 4056247, 4060223, 4063175, 4066289, 4070847, 4070848, 4075248, 4077074, 4080795, 4080796, 4083918, 4086015, 4089306, 4091397, 4097819, 4100891, 4100892, 4100893, 4107602, 4107603, 4110440, 4113103, 4116107, 4119097, 4122431, 4125812, 4128039, 4130980, 4134034, 4139026, 4142452, 4145685, 4147984, 4147986, 4147987, 4151040, 4153623, 4156626, 4159963, 4159964, 4159965, 4161976, 4163831, 4171582, 4171583, 4179346, 4179347, 4179348, 4179349, 4180477, 4180478, 4195804, 4196266, 4196267, 4197607, 4201340, 4204807, 4212766, 4212767, 4213413, 4216315, 4216316, 4216317, 4218700, 4218701, 4231488, 4233741, 4233954, 4237368, 4237369, 4237370, 4237371, 4240134, 4240135, 4240136, 4254225, 4254226, 4254227, 4260061, 4260062, 4267844, 4267845, 4267846, 4273421, 4273422, 4276457, 4276458, 4276459, 4279327, 4279328, 4283228, 4283229, 4283230, 4289472, 4289473, 4292161, 4322664, 4322665, 4327912, 4329826, 4329832, 4329837, 4331581, 4333980, 4334215, 4334216, 4334217, 4334950, 4334951, 4334971, 4344338, 4344339, 4344986, 4344987, 4344988, 4351226, 4357251, 4357252, 4357253, 4357254, 4362845, 4362846, 4362847, 4362848, 4362849, 4365788, 4365789, 4365790, 4365791, 4369576, 4369577, 4369578, 4383614, 4388136, 4388137, 4388138, 4389885, 4389886, 4393399, 4393400, 4393401, 4395768, 4395769, 4395770, 4399147, 4399148, 4399149; e) UDI/DI 10351688518705, Product Code/List Number/Item Code 67PFSS45, Lot Numbers: 3853425, 3868277, 3868278, 3868279, 3868280, 3868281, 3877663, 3880682, 3880683, 3887714, 3894879, 3901283, 3904662, 3907980, 3918011, 3930018, 3936580, 3939682, 3939683, 3939684, 3942525, 3942526, 3942527, 3955763, 3965912, 3965913, 3965914, 3965915, 3982051, 3982052, 3987967, 3988069, 3991136, 4005616, 4005617, 4011371, 4014485, 4014486, 4029501, 4033715, 4035720, 4040574, 4043941, 4048034, 4053700, 4056248, 4063176, 4066290, 4070849, 4077076, 4080797, 4083919, 4086020, 4091398, 4092644, 4096843, 4097817, 4107605, 4110441, 4116098, 4122432, 4128040, 4130983, 4134033, 4138981, 4145684, 4147991, 4151039, 4156622, 4159966, 4163830, 4168136, 4176231, 4179350, 4196268, 4197610, 4201367, 4204808, 4212768, 4216318, 4217438, 4231489, 4233955, 4237372, 4237373, 4237374, 4240137, 4247287, 4254228, 4260063, 4267847, 4273423, 4279329, 4279330, 4279331, 4283231, 4283232, 4283233, 4292162, 4322666, 4322667, 4327920, 4327921, 4334954, 4334955, 4334956, 4334957, 4334972, 4344989, 4344990, 4344991, 4355425, 4355427, 4355428, 4362860, 4362861, 4374418, 4374419, 4380077, 4380078, 4383615, 4383616, 4388139, 4388140, 4388141, 4389887, 4389888, 4393402, 4393403; f) UDI/DI 10351688518712, Product Code/List Number/Item Code 67PFSS50, Lot Numbers: 3840077, 3868270, 3868271, 3874322, 3880686, 3891521, 3894913, 3894914, 3897875, 3914573, 3917988, 3926973, 3930051, 3939654, 3939655, 3939656, 3942535, 3946255, 3946256, 3959320, 3959321, 3965926, 3982053, 3982055, 3997807, 4005627, 4011372, 4023785, 4029502, 4033716, 4035724, 4038945, 4043942, 4051668, 4056244, 4063177, 4070850, 4077107, 4083933, 4095913, 4100898, 4116099, 4125805, 4130999, 4138977, 4142439, 4151056, 4156645, 4159982, 4163847, 4176241, 4180480, 4196269, 4197611, 4201368, 4204809, 4213414, 4233956, 4247288, 4254229, 4260064, 4267848, 4279332, 4283234, 4289474, 4289475, 4292163, 4322668, 4328220, 4329828, 4331593, 4334219, 4334958, 4344343, 4344344, 4348423, 4348424, 4353079, 4353080, 4369579, 4369580, 4369581, 4369582, 4383617, 4383618, 4388142; g) UDI/DI 10351688518729, Product Code/List Number/Item Code 67PFSS55, Lot Numbers: 3868248, 3868282, 3868283, 3868284, 3880689, 3880690, 3880691, 3897873, 3911425, 3930017, 3931146, 3939677, 3939678, 3939679, 3946226, 3955766, 3982056, 3982057, 3997808, 4001128, 4005629, 4011373, 4018512, 4035725, 4041964, 4048030, 4051618, 4056249, 4071967, 4080800, 4089304, 4096844, 4105260, 4119095, 4125813, 4130979, 4136134, 4145690, 4151049, 4159957, 4163828, 4171584, 4179351, 4204810, 4212769, 4218702, 4233957, 4254230, 4260065, 4283235, 4289476, 4292164, 4327890, 4327923, 4328221, 4329827, 4329833, 4334218, 4344341, 4351227, 4362866, 4381007, 4383619, 4388144, 4388145, 4389889, 4395774, 4399156, 4399157, 4400652

Label field

Details supplied by the agency

Lot, code or applicability

a) UDI/DI 10351688518668, Product Code/List Number/Item Code 67PFSS25, Lot Numbers: 3897874, 3911416, 3923743, 4005596, 4016053, 4016057, 4080314, 4087038, 4217435, 4327880, 4334932, 4374412, 4381000; b) UDI/DI 10351688518675, Product Code/List Number/Item Code 67PFSS30, Lot Numbers: 3853409, 3853410, 3868326, 3871053, 3877650, 3887740, 3897845, 3923723, 3931154, 3939667, 3939668, 3946281, 3959294, 3961757, 3961758, 3981997, 3981998, 3987959, 3991133, 4005597, 4011365, 4035710, 4051637, 4051638, 4063173, 4071984, 4075246, 4089295, 4095916, 4096830, 4110438, 4116085, 4136131, 4138990, 4156656, 4159994, 4171580, 4171581, 4185411, 4195802, 4212764, 4217436, 4233952, 4254222, 4273418, 4276453, 4276454, 4279325, 4292159, 4322660, 4322661, 4327910, 4329839, 4334936, 4344353, 4344980, 4344981, 4348422, 4357249, 4357250, 4358491, 4358492, 4374413, 4380076, 4381001, 4383608, 4388128, 4388129, 4388130, 4389879, 4393395, 4395763, 4399143; c) UDI/DI 10351688518682, Product Code/List Number/Item Code 67PFSS35, Lot Numbers: 3835792, 3835793, 3853413, 3853414, 3858170, 3868261, 3868262, 3868263, 3868264, 3868265, 3868266, 3871041, 3871042, 3874323, 3880694, 3884245, 3884246, 3887727, 3891518, 3891519, 3894917, 3897876, 3901297, 3904685, 3911418, 3911419, 3917989, 3920964, 3923741, 3923742, 3930045, 3930046, 3933473, 3939641, 3939642, 3939643, 3939644, 3939645, 3942544, 3942545, 3942546, 3946257, 3946258, 3946259, 3946260, 3946261, 3946262, 3955809, 3955810, 3959312, 3959313, 3959314, 3962594, 3965924, 3965925, 3981999, 3982000, 3987962, 3987965, 3987984, 3991134, 4005598, 4005599, 4005605, 4005606, 4008203, 4008204, 4011366, 4011367, 4018508, 4018509, 4021421, 4023783, 4029500, 4033710, 4033711, 4035711, 4035712, 4035713, 4041963, 4043943, 4048012, 4051666, 4051667, 4053727, 4056245, 4056246, 4063174, 4066300, 4066301, 4067718, 4067719, 4067720, 4070846, 4075247, 4077104, 4077105, 4080787, 4080788, 4083925, 4086026, 4091405, 4091406, 4096848, 4097831, 4100900, 4107609, 4110439, 4116102, 4116122, 4119107, 4122428, 4125807, 4128028, 4131000, 4134036, 4134037, 4136129, 4139027, 4142442, 4142455, 4148021, 4148022, 4151058, 4151059, 4153585, 4156639, 4159984, 4163841, 4163843, 4168162, 4176243, 4176244, 4176246, 4176247, 4176248, 4179345, 4195803, 4196263, 4196264, 4196265, 4197606, 4201337, 4201338, 4201339, 4204806, 4212765, 4213412, 4216312, 4216313, 4216314, 4217437, 4218698, 4218699, 4231487, 4233953, 4237362, 4237363, 4237364, 4237365, 4237366, 4237367, 4240132, 4240133, 4247286, 4254223, 4254224, 4260059, 4260060, 4267840, 4267841, 4267842, 4273419, 4273420, 4276455, 4276456, 4279326, 4283224, 4283225, 4283226, 4283227, 4289470, 4289471, 4322662, 4322663, 4327911, 4328219, 4329825, 4329831, 4329836, 4334941, 4334942, 4334943, 4334944, 4334945, 4334946, 4334970, 4334973, 4344982, 4344983, 4344984, 4344985, 4351224, 4351225, 4352774, 4360417, 4360418, 4365787, 4369573, 4369574, 4369575, 4374414, 4374415, 4374416, 4374417, 4381002, 4381003, 4381004, 4381005, 4381006, 4383609, 4383610, 4383611, 4383612, 4388131, 4388132, 4388133, 4388134, 4388135, 4389880, 4389881, 4389882, 4389883, 4389884, 4393397; d) UDI/DI 10351688518699, Product Code/List Number/Item Code 67PFSS40, Lot Numbers: 3840066, 3853416, 3853417, 3853418, 3853419, 3853420, 3853421, 3868249, 3868250, 3868251, 3868252, 3874298, 3874299, 3877664, 3880692, 3884236, 3887724, 3891537, 3891538, 3894875, 3894876, 3901281, 3901282, 3904661, 3911426, 3911427, 3923728, 3930019, 3930020, 3933474, 3936585, 3939685, 3939686, 3939687, 3939688, 3942513, 3942514, 3942515, 3946293, 3946294, 3946295, 3946296, 3946297, 3946298, 3955756, 3955757, 3955758, 3962582, 3962583, 3962584, 3965918, 3982004, 3982005, 3982007, 3985840, 3985841, 3987966, 3987971, 3991135, 4005610, 4005611, 4005612, 4005614, 4008205, 4008206, 4011368, 4011370, 4015533, 4015534, 4018510, 4018511, 4021417, 4023784, 4026687, 4033713, 4033714, 4035715, 4035716, 4035717, 4040573, 4041965, 4048032, 4048033, 4051620, 4051621, 4053706, 4053707, 4056247, 4060223, 4063175, 4066289, 4070847, 4070848, 4075248, 4077074, 4080795, 4080796, 4083918, 4086015, 4089306, 4091397, 4097819, 4100891, 4100892, 4100893, 4107602, 4107603, 4110440, 4113103, 4116107, 4119097, 4122431, 4125812, 4128039, 4130980, 4134034, 4139026, 4142452, 4145685, 4147984, 4147986, 4147987, 4151040, 4153623, 4156626, 4159963, 4159964, 4159965, 4161976, 4163831, 4171582, 4171583, 4179346, 4179347, 4179348, 4179349, 4180477, 4180478, 4195804, 4196266, 4196267, 4197607, 4201340, 4204807, 4212766, 4212767, 4213413, 4216315, 4216316, 4216317, 4218700, 4218701, 4231488, 4233741, 4233954, 4237368, 4237369, 4237370, 4237371, 4240134, 4240135, 4240136, 4254225, 4254226, 4254227, 4260061, 4260062, 4267844, 4267845, 4267846, 4273421, 4273422, 4276457, 4276458, 4276459, 4279327, 4279328, 4283228, 4283229, 4283230, 4289472, 4289473, 4292161, 4322664, 4322665, 4327912, 4329826, 4329832, 4329837, 4331581, 4333980, 4334215, 4334216, 4334217, 4334950, 4334951, 4334971, 4344338, 4344339, 4344986, 4344987, 4344988, 4351226, 4357251, 4357252, 4357253, 4357254, 4362845, 4362846, 4362847, 4362848, 4362849, 4365788, 4365789, 4365790, 4365791, 4369576, 4369577, 4369578, 4383614, 4388136, 4388137, 4388138, 4389885, 4389886, 4393399, 4393400, 4393401, 4395768, 4395769, 4395770, 4399147, 4399148, 4399149; e) UDI/DI 10351688518705, Product Code/List Number/Item Code 67PFSS45, Lot Numbers: 3853425, 3868277, 3868278, 3868279, 3868280, 3868281, 3877663, 3880682, 3880683, 3887714, 3894879, 3901283, 3904662, 3907980, 3918011, 3930018, 3936580, 3939682, 3939683, 3939684, 3942525, 3942526, 3942527, 3955763, 3965912, 3965913, 3965914, 3965915, 3982051, 3982052, 3987967, 3988069, 3991136, 4005616, 4005617, 4011371, 4014485, 4014486, 4029501, 4033715, 4035720, 4040574, 4043941, 4048034, 4053700, 4056248, 4063176, 4066290, 4070849, 4077076, 4080797, 4083919, 4086020, 4091398, 4092644, 4096843, 4097817, 4107605, 4110441, 4116098, 4122432, 4128040, 4130983, 4134033, 4138981, 4145684, 4147991, 4151039, 4156622, 4159966, 4163830, 4168136, 4176231, 4179350, 4196268, 4197610, 4201367, 4204808, 4212768, 4216318, 4217438, 4231489, 4233955, 4237372, 4237373, 4237374, 4240137, 4247287, 4254228, 4260063, 4267847, 4273423, 4279329, 4279330, 4279331, 4283231, 4283232, 4283233, 4292162, 4322666, 4322667, 4327920, 4327921, 4334954, 4334955, 4334956, 4334957, 4334972, 4344989, 4344990, 4344991, 4355425, 4355427, 4355428, 4362860, 4362861, 4374418, 4374419, 4380077, 4380078, 4383615, 4383616, 4388139, 4388140, 4388141, 4389887, 4389888, 4393402, 4393403; f) UDI/DI 10351688518712, Product Code/List Number/Item Code 67PFSS50, Lot Numbers: 3840077, 3868270, 3868271, 3874322, 3880686, 3891521, 3894913, 3894914, 3897875, 3914573, 3917988, 3926973, 3930051, 3939654, 3939655, 3939656, 3942535, 3946255, 3946256, 3959320, 3959321, 3965926, 3982053, 3982055, 3997807, 4005627, 4011372, 4023785, 4029502, 4033716, 4035724, 4038945, 4043942, 4051668, 4056244, 4063177, 4070850, 4077107, 4083933, 4095913, 4100898, 4116099, 4125805, 4130999, 4138977, 4142439, 4151056, 4156645, 4159982, 4163847, 4176241, 4180480, 4196269, 4197611, 4201368, 4204809, 4213414, 4233956, 4247288, 4254229, 4260064, 4267848, 4279332, 4283234, 4289474, 4289475, 4292163, 4322668, 4328220, 4329828, 4331593, 4334219, 4334958, 4344343, 4344344, 4348423, 4348424, 4353079, 4353080, 4369579, 4369580, 4369581, 4369582, 4383617, 4383618, 4388142; g) UDI/DI 10351688518729, Product Code/List Number/Item Code 67PFSS55, Lot Numbers: 3868248, 3868282, 3868283, 3868284, 3880689, 3880690, 3880691, 3897873, 3911425, 3930017, 3931146, 3939677, 3939678, 3939679, 3946226, 3955766, 3982056, 3982057, 3997808, 4001128, 4005629, 4011373, 4018512, 4035725, 4041964, 4048030, 4051618, 4056249, 4071967, 4080800, 4089304, 4096844, 4105260, 4119095, 4125813, 4130979, 4136134, 4145690, 4151049, 4159957, 4163828, 4171584, 4179351, 4204810, 4212769, 4218702, 4233957, 4254230, 4260065, 4283235, 4289476, 4292164, 4327890, 4327923, 4328221, 4329827, 4329833, 4334218, 4344341, 4351227, 4362866, 4381007, 4383619, 4388144, 4388145, 4389889, 4395774, 4399156, 4399157, 4400652

Match all identifying details in the current notice. A brand name alone is not enough.

Distribution

Worldwide distribution.

No US distribution state could be established from this record. Check the official notice.

Dates in the source

Report date: Sep 4, 2024
Recall initiation date: May 29, 2024
Center classification date: Aug 23, 2024

FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.

What the record says

Lot and product identifiers

Distribution

Dates in the source

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