🔍 RecallPedia

PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) 3.0MM FLEXTEND PEDIATRIC STANDARD STRAIGHT TRACH TUBE , Product Code/List Number/Item Code 60PFSS30; b) 3.5MM FLEXTEND PEDIATRIC STANDARD STRAIGHT TRACH TUBE , Product Code/List Number/Item Code 60PFSS35; c) 4.0MM FLEXTEND PEDIATRIC STANDARD STRAIGHT TRACH TUBE TRACH TUBE , Product Code/List Number/Item Code 60PFSS40; d) 4.5MM FLEXTEND PEDIATRIC STANDARD STRAIGHT TRACH TUBE , Product Code/List Number/Item Code 60PFSS45; e) 5.0MM FLEXTEND PEDIATRIC STANDARD STRAIGHT TRACH TUBE , Product Code/List Number/Item Code 60PFSS50; f) 5.5MM FLEXTEND PEDIATRIC STANDARD STRAIGHT TRACH TUBE , Product Code/List Number/Item Code 60PFSS55

Class I - Dangerous
🏥 Medical Devices Recalled: May 29, 2024 Smiths Medical ASD Infusion Pumps

What Should You Do?

  1. Check if you have this product:
    a) UDI/DI 15021312516760, Product Code/List Number/Item Code 60PFSS30, Lot Numbers: 3868215, 3868216, 3868217, 3868218, 3874311, 3880720, 3887755, 3894894, 3904669, 3907971, 3917982, 3926967, 3933476, 3939635, 3942492, 3946278, 3946279, 3946280, 3962580, 3982686, 3988113, 3991183, 4001204, 4011379, 4011380, 4015559, 4029512, 4033728, 4033729, 4040575, 4048009, 4053713, 4060206, 4070853, 4077071, 4077072, 4083908, 4091412, 4096836, 4105256, 4110458, 4113107, 4119118, 4128037, 4130977, 4134021, 4142421, 4145693, 4151047, 4156612, 4159997, 4163851, 4171554, 4176212, 4176213, 4180497, 4185426, 4196281, 4201385, 4204821, 4206823, 4209570, 4212783, 4217447, 4218710, 4221348, 4231505, 4231506, 4254255, 4260070, 4267849, 4273428, 4283245, 4289488, 4289489, 4292174, 4322678, 4327893, 4335022, 4335024, 4345018, 4345019, 4345021, 4351242, 4352791, 4374450, 4374451, 4374452, 4374453, 4381024, 4381025, 4381026, 4383637, 4388183, 4388184, 4388185, 4388186, 4389907, 4395792, 4395793, 4399193, 4399195, 4400678; b) UDI/DI 15021312516777, Product Code/List Number/Item Code 60PFSS35, Lot Numbers: 3840073, 3840074, 3845208, 3853467, 3853468, 3853469, 3858171, 3861148, 3863922, 3864208, 3868324, 3868325, 3871034, 3871035, 3874315, 3874316, 3874317, 3874318, 3874319, 3874320, 3877667, 3880698, 3880699, 3894862, 3894863, 3894864, 3897856, 3897857, 3897858, 3901284, 3901285, 3903698, 3907977, 3907978, 3907979, 3917978, 3917979, 3920968, 3923714, 3926978, 3926979, 3930039, 3931139, 3939626, 3939627, 3939628, 3942452, 3942453, 3942454, 3946232, 3946233, 3946234, 3946235, 3946236, 3946237, 3946238, 3946239, 3946240, 3950393, 3955795, 3959329, 3959330, 3959331, 3959332, 3959333, 3982687, 3982688, 3982689, 3982690, 3988114, 3988115, 3988116, 3988117, 3988118, 3988119, 3988120, 3991184, 3991185, 3991186, 3997830, 3997831, 3997832, 4001205, 4005667, 4005668, 4008220, 4008221, 4011381, 4015560, 4015561, 4015563, 4018523, 4018525, 4026693, 4029513, 4033731, 4035749, 4035750, 4035751, 4035752, 4041967, 4041968, 4043935, 4048029, 4051627, 4051628, 4053721, 4053722, 4053723, 4053724, 4053725, 4060207, 4060208, 4063189, 4066281, 4066282, 4071978, 4071979, 4075237, 4075238, 4077091, 4080785, 4083909, 4083910, 4089298, 4092630, 4092631, 4093738, 4095922, 4097812, 4100877, 4100878, 4100879, 4100880, 4100881, 4107596, 4107597, 4110459, 4110460, 4113100, 4113101, 4119121, 4122430, 4125809, 4125810, 4128021, 4128022, 4130989, 4134022, 4136150, 4138980, 4142449, 4142450, 4145703, 4147998, 4147999, 4151032, 4153611, 4156608, 4159938, 4161966, 4161967, 4161969, 4163816, 4168154, 4171555, 4176218, 4179362, 4179363, 4179364, 4180490, 4185427, 4196282, 4196283, 4196284, 4197619, 4197620, 4197621, 4201386, 4204822, 4206824, 4206825, 4206826, 4209571, 4209572, 4209573, 4212784, 4216326, 4216327, 4216328, 4218711, 4221349, 4221350, 4223733, 4223734, 4226265, 4231507, 4231508, 4231509, 4233970, 4233971, 4237387, 4237388, 4237389, 4240155, 4240157, 4240158, 4240161, 4254256, 4254258, 4260071, 4267850, 4267851, 4267852, 4273429, 4273430, 4273431, 4273432, 4276468, 4276469, 4276470, 4276471, 4279337, 4279338, 4279339, 4283246, 4283247, 4283248, 4286806, 4286807, 4286808, 4289490, 4289491, 4292175, 4322679, 4322680, 4327896, 4327897, 4331616, 4331617, 4331618, 4331619, 4335029, 4335030, 4335031, 4335032, 4335033, 4335034, 4345022, 4345023, 4345024, 4345025, 4345026, 4351243, 4351245, 4352792, 4352793, 4360411, 4360412, 4360413, 4369605, 4369606, 4369607, 4369608, 4374455, 4374456, 4374457, 4381027, 4381028, 4381029, 4383638, 4383639, 4383640, 4383641, 4383642, 4388187, 4388188, 4388189, 4388190, 4389908, 4389909, 4393411, 4393415; c) UDI/DI 15021312516784, Product Code/List Number/Item Code 60PFSS40, Lot Numbers: 3853472, 3868234, 3868235, 3868236, 3868237, 3868238, 3868239, 3868241, 3868242, 3868243, 3868244, 3871051, 3880704, 3884253, 3887750, 3887751, 3891514, 3891515, 3894870, 3894871, 3894872, 3894873, 3897870, 3897871, 3901299, 3901300, 3903699, 3917983, 3920944, 3920945, 3926959, 3939638, 3942475, 3942476, 3942477, 3942478, 3942479, 3942480, 3942481, 3946247, 3946248, 3946249, 3946250, 3946251, 3946252, 3959295, 3959296, 3959297, 3959298, 3982691, 3982692, 3982693, 3988121, 3988122, 3988123, 3988124, 3988125, 3988126, 3988127, 3991189, 3991190, 3991191, 3991192, 3991193, 3991194, 3997833, 4001208, 4001210, 4001211, 4005672, 4008222, 4008223, 4008224, 4011382, 4015564, 4015565, 4015567, 4015568, 4015569, 4033732, 4033733, 4035753, 4035754, 4040576, 4041970, 4041971, 4048014, 4051635, 4051636, 4053697, 4053698, 4056232, 4056233, 4060215, 4060216, 4063190, 4066283, 4066284, 4071982, 4071983, 4075239, 4075240, 4089303, 4092636, 4093739, 4097814, 4100884, 4100885, 4107612, 4107613, 4110461, 4113109, 4113110, 4116104, 4119086, 4119087, 4125820, 4128024, 4128025, 4130995, 4130996, 4134030, 4134031, 4136149, 4138993, 4142424, 4142425, 4145715, 4148003, 4148004, 4151054, 4153575, 4156631, 4159949, 4161979, 4163826, 4168165, 4168167, 4171556, 4176223, 4176224, 4179365, 4179366, 4180450, 4185428, 4196285, 4196286, 4196287, 4197622, 4197623, 4201387, 4201388, 4204823, 4206827, 4206828, 4206829, 4209574, 4209575, 4209576, 4209577, 4216329, 4216330, 4218712, 4221351, 4221352, 4223735, 4223736, 4226266, 4231510, 4231511, 4231512, 4233972, 4233973, 4233974, 4234637, 4234638, 4237390, 4237391, 4237392, 4240160, 4247293, 4254261, 4254262, 4260072, 4260073, 4267853, 4267854, 4267855, 4267856, 4273433, 4273434, 4273435, 4273436, 4276472, 4276473, 4276474, 4279340, 4279341, 4283249, 4286809, 4286810, 4286811, 4289492, 4289493, 4289494, 4292176, 4322681, 4322682, 4327900, 4327901, 4327934, 4331622, 4331623, 4335040, 4335041, 4335042, 4335043, 4335044, 4345028, 4345029, 4345030, 4345031, 4345032, 4345033, 4345034, 4348478, 4348479, 4348480, 4352797, 4352798, 4357238, 4357239, 4357240, 4357241, 4357242, 4357243, 4358509, 4365780, 4369609, 4369610, 4369611, 4374458, 4374459, 4374460, 4379946, 4379953, 4379954, 4381030, 4381031, 4383643, 4383644, 4383645, 4383646, 4388191, 4388192, 4388193, 4388194, 4389913, 4389914, 4389915, 4389916, 4389917, 4393418, 4393419, 4399203; d) UDI/DI 15021312516791, Product Code/List Number/Item Code 60PFSS45, Lot Numbers: 3853473, 3853474, 3868198, 3868199, 3874305, 3880707, 3884261, 3894905, 3897859, 3904674, 3908003, 3918013, 3926960, 3930026, 3930027, 3939624, 3939669, 3942482, 3946291, 3946292, 3955775, 3955776, 3962573, 3982694, 3982695, 3988128, 3988129, 3991195, 3991196, 3991197, 3991198, 3991199, 4001213, 4001214, 4008225, 4008226, 4015570, 4015571, 4023790, 4033736, 4035755, 4040577, 4048026, 4051644, 4051645, 4056242, 4060218, 4060219, 4063191, 4066293, 4071974, 4083911, 4091393, 4093740, 4097836, 4105254, 4107585, 4110462, 4116091, 4122447, 4125825, 4128017, 4139001, 4145697, 4148015, 4151029, 4153609, 4159951, 4161965, 4176227, 4185429, 4196288, 4196289, 4197625, 4201390, 4206830, 4206831, 4209578, 4209579, 4212785, 4216331, 4217449, 4218713, 4226267, 4231513, 4231514, 4231515, 4233975, 4237393, 4240162, 4247294, 4254264, 4260074, 4267857, 4267858, 4273437, 4276475, 4276476, 4279342, 4279343, 4283250, 4283251, 4286812, 4292177, 4322683, 4335045, 4335046, 4335047, 4345035, 4347209, 4347210, 4351246, 4352794, 4353059, 4353060, 4355429, 4355430, 4374461, 4374462, 4374463, 4379948, 4379962, 4383647, 4383648, 4383649, 4388196, 4388197, 4388198, 4389918, 4393420, 4393421; e) UDI/DI 15021312516807, Product Code/List Number/Item Code 60PFSS50, Lot Numbers: 3840057, 3868220, 3868221, 3868222, 3880714, 3884270, 3894907, 3897868, 3904679, 3911436, 3918023, 3920950, 3930029, 3930030, 3946241, 3946242, 3946243, 3949030, 3982696, 3991200, 3991201, 4008227, 4011383, 4015572, 4023791, 4026696, 4033737, 4035756, 4043934, 4051656, 4053710, 4071975, 4083923, 4086011, 4097837, 4110463, 4122454, 4128023, 4139014, 4145698, 4156619, 4161975, 4168152, 4176234, 4185430, 4196290, 4201391, 4206832, 4212786, 4218714, 4223737, 4231516, 4254266, 4267859, 4276477, 4279344, 4289495, 4322684, 4327905, 4335048, 4335049, 4345036, 4345038, 4351247, 4352795, 4365781, 4365782, 4365783, 4374464, 4383650, 4383651, 4389919, 4393422, 4393423; f) UDI/DI 15021312516814, Product Code/List Number/Item Code 60PFSS55, Lot Numbers: 3868230, 3871032, 3880678, 3887732, 3894906, 3904653, 3911421, 3920954, 3923729, 3930009, 3930010, 3930011, 3946277, 3982697, 3997820, 4008228, 4015573, 4021424, 4026680, 4035757, 4051657, 4063192, 4077087, 4085995, 4091411, 4107589, 4116089, 4125802, 4128013, 4134015, 4142435, 4142436, 4151026, 4156661, 4161961, 4171558, 4180466, 4196291, 4201392, 4212787, 4231517, 4267860, 4279345, 4292178, 4322685, 4327891, 4327907, 4335050, 4345037, 4351248, 4352796, 4374465, 4383652, 4388199, 4388200, 4389920, 4399207, 4399209, 4400689
  2. Do not eat it: Even if it looks and smells fine, do not consume this product.
  3. Throw it away or return it: You can return the product to the store for a full refund.
  4. Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
  5. Report problems: Report any issues to the FDA's Safety Reporting Portal.

⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.

Recall Details

Company:
Smiths Medical ASD Inc.
Reason for Recall:
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 - Dangerous

Dangerous or defective products that predictably could cause serious health problems or death.

Status:
ongoing

Product Information

Full Description:

PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) 3.0MM FLEXTEND PEDIATRIC STANDARD STRAIGHT TRACH TUBE , Product Code/List Number/Item Code 60PFSS30; b) 3.5MM FLEXTEND PEDIATRIC STANDARD STRAIGHT TRACH TUBE , Product Code/List Number/Item Code 60PFSS35; c) 4.0MM FLEXTEND PEDIATRIC STANDARD STRAIGHT TRACH TUBE TRACH TUBE , Product Code/List Number/Item Code 60PFSS40; d) 4.5MM FLEXTEND PEDIATRIC STANDARD STRAIGHT TRACH TUBE , Product Code/List Number/Item Code 60PFSS45; e) 5.0MM FLEXTEND PEDIATRIC STANDARD STRAIGHT TRACH TUBE , Product Code/List Number/Item Code 60PFSS50; f) 5.5MM FLEXTEND PEDIATRIC STANDARD STRAIGHT TRACH TUBE , Product Code/List Number/Item Code 60PFSS55

Product Codes/Lot Numbers:

a) UDI/DI 15021312516760, Product Code/List Number/Item Code 60PFSS30, Lot Numbers: 3868215, 3868216, 3868217, 3868218, 3874311, 3880720, 3887755, 3894894, 3904669, 3907971, 3917982, 3926967, 3933476, 3939635, 3942492, 3946278, 3946279, 3946280, 3962580, 3982686, 3988113, 3991183, 4001204, 4011379, 4011380, 4015559, 4029512, 4033728, 4033729, 4040575, 4048009, 4053713, 4060206, 4070853, 4077071, 4077072, 4083908, 4091412, 4096836, 4105256, 4110458, 4113107, 4119118, 4128037, 4130977, 4134021, 4142421, 4145693, 4151047, 4156612, 4159997, 4163851, 4171554, 4176212, 4176213, 4180497, 4185426, 4196281, 4201385, 4204821, 4206823, 4209570, 4212783, 4217447, 4218710, 4221348, 4231505, 4231506, 4254255, 4260070, 4267849, 4273428, 4283245, 4289488, 4289489, 4292174, 4322678, 4327893, 4335022, 4335024, 4345018, 4345019, 4345021, 4351242, 4352791, 4374450, 4374451, 4374452, 4374453, 4381024, 4381025, 4381026, 4383637, 4388183, 4388184, 4388185, 4388186, 4389907, 4395792, 4395793, 4399193, 4399195, 4400678; b) UDI/DI 15021312516777, Product Code/List Number/Item Code 60PFSS35, Lot Numbers: 3840073, 3840074, 3845208, 3853467, 3853468, 3853469, 3858171, 3861148, 3863922, 3864208, 3868324, 3868325, 3871034, 3871035, 3874315, 3874316, 3874317, 3874318, 3874319, 3874320, 3877667, 3880698, 3880699, 3894862, 3894863, 3894864, 3897856, 3897857, 3897858, 3901284, 3901285, 3903698, 3907977, 3907978, 3907979, 3917978, 3917979, 3920968, 3923714, 3926978, 3926979, 3930039, 3931139, 3939626, 3939627, 3939628, 3942452, 3942453, 3942454, 3946232, 3946233, 3946234, 3946235, 3946236, 3946237, 3946238, 3946239, 3946240, 3950393, 3955795, 3959329, 3959330, 3959331, 3959332, 3959333, 3982687, 3982688, 3982689, 3982690, 3988114, 3988115, 3988116, 3988117, 3988118, 3988119, 3988120, 3991184, 3991185, 3991186, 3997830, 3997831, 3997832, 4001205, 4005667, 4005668, 4008220, 4008221, 4011381, 4015560, 4015561, 4015563, 4018523, 4018525, 4026693, 4029513, 4033731, 4035749, 4035750, 4035751, 4035752, 4041967, 4041968, 4043935, 4048029, 4051627, 4051628, 4053721, 4053722, 4053723, 4053724, 4053725, 4060207, 4060208, 4063189, 4066281, 4066282, 4071978, 4071979, 4075237, 4075238, 4077091, 4080785, 4083909, 4083910, 4089298, 4092630, 4092631, 4093738, 4095922, 4097812, 4100877, 4100878, 4100879, 4100880, 4100881, 4107596, 4107597, 4110459, 4110460, 4113100, 4113101, 4119121, 4122430, 4125809, 4125810, 4128021, 4128022, 4130989, 4134022, 4136150, 4138980, 4142449, 4142450, 4145703, 4147998, 4147999, 4151032, 4153611, 4156608, 4159938, 4161966, 4161967, 4161969, 4163816, 4168154, 4171555, 4176218, 4179362, 4179363, 4179364, 4180490, 4185427, 4196282, 4196283, 4196284, 4197619, 4197620, 4197621, 4201386, 4204822, 4206824, 4206825, 4206826, 4209571, 4209572, 4209573, 4212784, 4216326, 4216327, 4216328, 4218711, 4221349, 4221350, 4223733, 4223734, 4226265, 4231507, 4231508, 4231509, 4233970, 4233971, 4237387, 4237388, 4237389, 4240155, 4240157, 4240158, 4240161, 4254256, 4254258, 4260071, 4267850, 4267851, 4267852, 4273429, 4273430, 4273431, 4273432, 4276468, 4276469, 4276470, 4276471, 4279337, 4279338, 4279339, 4283246, 4283247, 4283248, 4286806, 4286807, 4286808, 4289490, 4289491, 4292175, 4322679, 4322680, 4327896, 4327897, 4331616, 4331617, 4331618, 4331619, 4335029, 4335030, 4335031, 4335032, 4335033, 4335034, 4345022, 4345023, 4345024, 4345025, 4345026, 4351243, 4351245, 4352792, 4352793, 4360411, 4360412, 4360413, 4369605, 4369606, 4369607, 4369608, 4374455, 4374456, 4374457, 4381027, 4381028, 4381029, 4383638, 4383639, 4383640, 4383641, 4383642, 4388187, 4388188, 4388189, 4388190, 4389908, 4389909, 4393411, 4393415; c) UDI/DI 15021312516784, Product Code/List Number/Item Code 60PFSS40, Lot Numbers: 3853472, 3868234, 3868235, 3868236, 3868237, 3868238, 3868239, 3868241, 3868242, 3868243, 3868244, 3871051, 3880704, 3884253, 3887750, 3887751, 3891514, 3891515, 3894870, 3894871, 3894872, 3894873, 3897870, 3897871, 3901299, 3901300, 3903699, 3917983, 3920944, 3920945, 3926959, 3939638, 3942475, 3942476, 3942477, 3942478, 3942479, 3942480, 3942481, 3946247, 3946248, 3946249, 3946250, 3946251, 3946252, 3959295, 3959296, 3959297, 3959298, 3982691, 3982692, 3982693, 3988121, 3988122, 3988123, 3988124, 3988125, 3988126, 3988127, 3991189, 3991190, 3991191, 3991192, 3991193, 3991194, 3997833, 4001208, 4001210, 4001211, 4005672, 4008222, 4008223, 4008224, 4011382, 4015564, 4015565, 4015567, 4015568, 4015569, 4033732, 4033733, 4035753, 4035754, 4040576, 4041970, 4041971, 4048014, 4051635, 4051636, 4053697, 4053698, 4056232, 4056233, 4060215, 4060216, 4063190, 4066283, 4066284, 4071982, 4071983, 4075239, 4075240, 4089303, 4092636, 4093739, 4097814, 4100884, 4100885, 4107612, 4107613, 4110461, 4113109, 4113110, 4116104, 4119086, 4119087, 4125820, 4128024, 4128025, 4130995, 4130996, 4134030, 4134031, 4136149, 4138993, 4142424, 4142425, 4145715, 4148003, 4148004, 4151054, 4153575, 4156631, 4159949, 4161979, 4163826, 4168165, 4168167, 4171556, 4176223, 4176224, 4179365, 4179366, 4180450, 4185428, 4196285, 4196286, 4196287, 4197622, 4197623, 4201387, 4201388, 4204823, 4206827, 4206828, 4206829, 4209574, 4209575, 4209576, 4209577, 4216329, 4216330, 4218712, 4221351, 4221352, 4223735, 4223736, 4226266, 4231510, 4231511, 4231512, 4233972, 4233973, 4233974, 4234637, 4234638, 4237390, 4237391, 4237392, 4240160, 4247293, 4254261, 4254262, 4260072, 4260073, 4267853, 4267854, 4267855, 4267856, 4273433, 4273434, 4273435, 4273436, 4276472, 4276473, 4276474, 4279340, 4279341, 4283249, 4286809, 4286810, 4286811, 4289492, 4289493, 4289494, 4292176, 4322681, 4322682, 4327900, 4327901, 4327934, 4331622, 4331623, 4335040, 4335041, 4335042, 4335043, 4335044, 4345028, 4345029, 4345030, 4345031, 4345032, 4345033, 4345034, 4348478, 4348479, 4348480, 4352797, 4352798, 4357238, 4357239, 4357240, 4357241, 4357242, 4357243, 4358509, 4365780, 4369609, 4369610, 4369611, 4374458, 4374459, 4374460, 4379946, 4379953, 4379954, 4381030, 4381031, 4383643, 4383644, 4383645, 4383646, 4388191, 4388192, 4388193, 4388194, 4389913, 4389914, 4389915, 4389916, 4389917, 4393418, 4393419, 4399203; d) UDI/DI 15021312516791, Product Code/List Number/Item Code 60PFSS45, Lot Numbers: 3853473, 3853474, 3868198, 3868199, 3874305, 3880707, 3884261, 3894905, 3897859, 3904674, 3908003, 3918013, 3926960, 3930026, 3930027, 3939624, 3939669, 3942482, 3946291, 3946292, 3955775, 3955776, 3962573, 3982694, 3982695, 3988128, 3988129, 3991195, 3991196, 3991197, 3991198, 3991199, 4001213, 4001214, 4008225, 4008226, 4015570, 4015571, 4023790, 4033736, 4035755, 4040577, 4048026, 4051644, 4051645, 4056242, 4060218, 4060219, 4063191, 4066293, 4071974, 4083911, 4091393, 4093740, 4097836, 4105254, 4107585, 4110462, 4116091, 4122447, 4125825, 4128017, 4139001, 4145697, 4148015, 4151029, 4153609, 4159951, 4161965, 4176227, 4185429, 4196288, 4196289, 4197625, 4201390, 4206830, 4206831, 4209578, 4209579, 4212785, 4216331, 4217449, 4218713, 4226267, 4231513, 4231514, 4231515, 4233975, 4237393, 4240162, 4247294, 4254264, 4260074, 4267857, 4267858, 4273437, 4276475, 4276476, 4279342, 4279343, 4283250, 4283251, 4286812, 4292177, 4322683, 4335045, 4335046, 4335047, 4345035, 4347209, 4347210, 4351246, 4352794, 4353059, 4353060, 4355429, 4355430, 4374461, 4374462, 4374463, 4379948, 4379962, 4383647, 4383648, 4383649, 4388196, 4388197, 4388198, 4389918, 4393420, 4393421; e) UDI/DI 15021312516807, Product Code/List Number/Item Code 60PFSS50, Lot Numbers: 3840057, 3868220, 3868221, 3868222, 3880714, 3884270, 3894907, 3897868, 3904679, 3911436, 3918023, 3920950, 3930029, 3930030, 3946241, 3946242, 3946243, 3949030, 3982696, 3991200, 3991201, 4008227, 4011383, 4015572, 4023791, 4026696, 4033737, 4035756, 4043934, 4051656, 4053710, 4071975, 4083923, 4086011, 4097837, 4110463, 4122454, 4128023, 4139014, 4145698, 4156619, 4161975, 4168152, 4176234, 4185430, 4196290, 4201391, 4206832, 4212786, 4218714, 4223737, 4231516, 4254266, 4267859, 4276477, 4279344, 4289495, 4322684, 4327905, 4335048, 4335049, 4345036, 4345038, 4351247, 4352795, 4365781, 4365782, 4365783, 4374464, 4383650, 4383651, 4389919, 4393422, 4393423; f) UDI/DI 15021312516814, Product Code/List Number/Item Code 60PFSS55, Lot Numbers: 3868230, 3871032, 3880678, 3887732, 3894906, 3904653, 3911421, 3920954, 3923729, 3930009, 3930010, 3930011, 3946277, 3982697, 3997820, 4008228, 4015573, 4021424, 4026680, 4035757, 4051657, 4063192, 4077087, 4085995, 4091411, 4107589, 4116089, 4125802, 4128013, 4134015, 4142435, 4142436, 4151026, 4156661, 4161961, 4171558, 4180466, 4196291, 4201392, 4212787, 4231517, 4267860, 4279345, 4292178, 4322685, 4327891, 4327907, 4335050, 4345037, 4351248, 4352796, 4374465, 4383652, 4388199, 4388200, 4389920, 4399207, 4399209, 4400689

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-2601-2024

Related Recalls

CADD-Solis HPCA Ambulatory Infusion Pump; Model/Number: 21-2111-0402-09-KYO 21-2111-0402-09-KYO CADD SOLIS PIB PUMP FOR CLINICAL EVALUATION/DEMO PUMP 21-2111-0300-09_LOAN CADD SOLIS PIB PUMP FOR CLINICAL EVALUATION/DEMO PUMP FOR CMSA 21-2111-0300-09_CMSA CADD Solis PIB PUMP FOR CLINICAL EVALUATION/DEMO PUMP FOR FUKUOKA 21-2111-0300-09_FUK CADD SOLIS PIB PUMP FOR CLINICAL EVALUATION/DEMO PUMP FOR KYOTO 21-2111-0300-09_KYO CADD SOLIS PIB PUMP FOR CLINICAL EVALUATION/DEMO PUMP FOR OKAYAMA 21-2111-0300-09_OKA CADD SOLIS PIB PUMP FOR CLINICAL EVALUATION/DEMO PUMP FOR OOMIYA 21-2111-0300-09_OMI CADD SOLIS PIB PUMP FOR CLINICAL EVALUATION/DEMO PUMP FOR OSAKA 21-2111-0300-09_OSA CADD SOLIS PIB PUMP FOR CLINICAL EVALUATION/DEMO PUMP FOR SAPPORO 21-2111-0300-09_SAP CADD SOLIS PIB PUMP FOR CLINICAL EVALUATION/DEMO PUMP FOR TOKYO 21-2111-0300-09_TOK CADD_SOLIS_MODEL 2110_ENGLISH_1/EA 21-2111-0200-50JP CADD-Solis VIP CADD-SOLIS V4.2 LOAN FUK 21-2111-0402-09-FUK CADD-SOLIS V4.2 LOAN NAG 21-2111-0402-09-NAG CADD-SOLIS V4.2 LOAN OKA 21-2111-0402-09-OKA CADD-SOLIS V4.2 LOAN OSA 21-2111-0402-09-OSA CADD-SOLIS V4.2 LOAN SAI 21-2111-0402-09-SAI CADD-SOLIS V4.2 LOAN SAP 21-2111-0402-09-SAP CADD-SOLIS V4.2 LOAN TOKE 21-2111-0402-09-TOKE CADD-SOLIS V4.2 LOAN TOKW 21-2111-0402-09-TOKW CADD-SOLIS V4.2 LOAN YELLOW KYO 21-2112-0402-09-KYO CADD-SOLIS V4.2 LOAN YELLOW NAG 21-2112-0402-09-NAG CADD-SOLIS V4.2 LOAN YELLOW YOK ¿ 21-2112-0402-09-YOK CADD-SOLIS V4.2 LOAN YOK 21-2111-0402-09-YOK Number:21-2111-0403-02Part Type:List Number/Finished GoodLifecycle Phase:03-ReleasedDescription:PUMP KIT, CADD SOLIS HPCA, MDL 2110, V4.3, FRENCH, 1/EA 21-2111-0403-02 PUMP KIT, CADD SOLIS HPCA, MDL 2110, V4.3, ENGLISH, 1/EA 21-2111-0403-51 PUMP KIT, CADD SOLIS HPCA, MDL 2110, V4.3, TRIAL, LOANER, ENGLISH, 1/EA 21-2111-0403-78 PUMP KIT, CADD SOLIS HPCA, MDL 2110, V4.3, TRIAL, LOANER, YELLOW, ENGLISH, 1/EA 21-2112-0403-78 PUMP KIT, CADD SOLIS HPCA, MDL 2110, V4.3, YELLOW, ENGLISH, 1/EA 21-2112-0403-51 PUMP KIT, CADD SOLIS HPCA, MDL 2110, V4.3, YELLOW, FRENCH, 1/EA 21-2112-0403-02 PUMP KIT, CADD-SOLIS HPCA PIB, MODEL 2110 TRIAL/LOANER, NA ENGLISH 1/EA 21-2111-0300-00 PUMP KIT, CADD-SOLIS HPCA PIB, MODEL 2110, DANISH 1/EA ¿ 21-2111-0300-12 PUMP KIT, CADD-SOLIS HPCA PIB, MODEL 2110, DUTCH 1/EA ¿ 21-2111-0300-06 PUMP KIT, CADD-SOLIS HPCA PIB, MODEL 2110, FRENCH 1/EA ¿ 21-2111-0300-02 PUMP KIT, CADD-SOLIS HPCA PIB, MODEL 2110, GERMAN 1/EA ¿ 21-2111-0300-03 PUMP KIT, CADD-SOLIS HPCA PIB, MODEL 2110, ITALIAN 1/EA ¿ 21-2111-0300-07 PUMP KIT, CADD-SOLIS HPCA PIB, MODEL 2110, JAPANESE 21-2111-0300-09JP PUMP KIT, CADD-SOLIS HPCA PIB, MODEL 2110, NA ENGLISH 1/EA ¿ 21-2111-0300-01 PUMP KIT, CADD-SOLIS HPCA PIB, MODEL 2110, NFHU, FRENCH 1/EA ¿ 21-2111-0300-232 PUMP KIT, CADD-SOLIS HPCA PIB, MODEL 2110, NFHU, NA ENGLISH 1/EA ¿ 21-2111-0300-231 PUMP KIT, CADD-SOLIS HPCA PIB, MODEL 2110, NFHU, SWEDISH 1/EA 21-2111-0300-244 PUMP KIT, CADD-SOLIS HPCA PIB, MODEL 2110, OUS ENGLISH 1/EA ¿ 21-2111-0300-50 Not PUMP KIT, CADD-SOLIS HPCA PIB, MODEL 2110, PORTUGUESE 1/EA ¿ 21-2111-0300-17 PUMP KIT, CADD-SOLIS HPCA PIB, MODEL 2110, SPANISH 1/EA ¿ 21-2111-0300-08 PUMP KIT, CADD-SOLIS HPCA PIB, MODEL 2110, SWEDISH 1/EA ¿ 21-2111-0300-14 PUMP KIT, CADD-SOLIS HPCA PIB, YELLOW KEYPAD, MODEL 2110, NA ENGLISH 1/EA ¿ 21-2112-0300-01 PUMP KIT, CADD-SOLIS HPCA PIB, YELLOW, MODEL 2110, DUTCH 1/EA 21-2112-0300-06 PUMP KIT, CADD-SOLIS HPCA PIB, YELLOW, MODEL 2110, FRENCH 1/EA ¿ 21-2112-0300-02 PUMP KIT, CADD-SOLIS HPCA PIB, YELLOW, MODEL 2110, GERMAN 1/EA 21-2112-0300-03 PUMP KIT, CADD-SOLIS HPCA PIB, YELLOW, MODEL 2110, OUS ENGLISH 1/EA 21-2112-0300-50 PUMP KIT, CADD-SOLIS HPCA PIB, YELLOW, MODEL 2110,TRIAL/LOANER, NA ENGLISH 1/EA 21-2112-0300-00 PUMP KIT, CADD-SOLIS HPCA, MDL 2100, DANISH 1/EA ¿ 21-2101-0200-12 PUMP KIT, CADD-SOLIS HPCA, MDL 2100, FRENCH 1/EA ¿ 21-2101-0200-02 PUMP KIT, CADD-SOLIS HPCA, MDL 2100, GERMAN 1/EA ¿ 21-2101-0200-03 PUMP KIT, CADD-SOLIS HPCA, MDL 2100, ITALIAN 1/EA ¿ 21-2101-02

Smiths Medical ASD

Class I - Dangerous

Affected pumps may trigger an erroneous (false) Upstream Occlusion Alarm under certain conditions, which will interrupt an active infusion. Interruption or delay of therapy can lead to serious patient injury or death.

Apr 10, 2025 Infusion Pumps Nationwide View Details →

CADD-Solis VIP Ambulatory Infusion Pump; Model/Number: 21-2120-0100-02 21-2120-0100-03 21-2120-0100-06 21-2120-0100-232 21-2120-0100-233 21-2120-0100-50 21-2120-0100-51 21-2120-0100-95 21-2120-0102-02 21-2120-0102-03 21-2120-0102-06 21-2120-0102-07 21-2120-0102-08 21-2120-0102-12 21-2120-0102-13 21-2120-0102-14 21-2120-0102-15 21-2120-0102-17 21-2120-0102-237 21-2120-0102-238 21-2120-0102-247 21-2120-0102-249 21-2120-0102-51 21-2120-0102-78 21-2120-0102-92 21-2120-0102-97 21-2120-0102-98 21-2120-0103-01 21-2120-0103-02 21-2120-0103-03 21-2120-0103-06 21-2120-0103-07 21-2120-0103-08 21-2120-0103-12 21-2120-0103-14 21-2120-0103-15 21-2120-0103-17 21-2120-0103-249 21-2120-0103-51 21-2120-0103-78 21-2120-0104-01 21-2120-0104-231 21-2120-0105-00 21-2120-0105-01 21-2120-0105-02L 21-2120-0105-03L 21-2120-0105-06L 21-2120-0105-07L 21-2120-0105-08 21-2120-0105-08L 21-2120-0105-12L 21-2120-0105-13L 21-2120-0105-14L 21-2120-0105-15L 21-2120-0105-17L 21-2120-0105-50 21-2120-0105-50L 21-2125-0104-01 21-2125-0105-03L 21-2125-0105-07L 21-2125-0105-08L 21-2125-0105-50L 21-2127-0104-01 21-2127-0105-01 21-2127-0105-02L 21-2127-0105-03L 21-2127-0105-06L 21-2127-0105-08L 21-2127-0105-50L

Smiths Medical ASD

Class I - Dangerous

Affected pumps may trigger an erroneous (false) Upstream Occlusion Alarm under certain conditions, which will interrupt an active infusion. Interruption or delay of therapy can lead to serious patient injury or death.

Apr 10, 2025 Infusion Pumps Nationwide View Details →

CADD Solis VIP Ambulatory Infusion Pump Models: 1) PUMP KIT, CADD-SOLIS VIP, MDL 2120, NA ENGLISH, MANUAL MODE, 1/EA, Model Number: 21-2127-0105-01; 2) PUMP KIT, CADD-SOLIS VIP, MDL 2120, NA ENGLISH, PHARMGUARD ENABLED, 1/EA, Model Number: 21-2120-0105-01; 3) PUMP KIT, CADD-SOLIS VIP, MDL 2120, NA ENGLISH 1/EA, Model Number: 21-2120-0103-01; 4) PUMP, CADD-SOLIS VIP, MDL 2120, ENGLISH 1/EA, Model Number: 21-2120-0102-51; 5) PUMP KIT, CADD-SOLIS VIP, MDL 2120, NA ENGLISH, PHARMGUARD ENABLED 1/EA, Model Number: 21-2120-0104-01; 6) PUMP KIT, CADD-SOLIS VIP, MDL 2120, CE GLOBAL ENGLISH 1/EA, Model Number: 21-2120-0103-51; 7) PUMP KIT, CADD-SOLIS VIP, MDL 2120, NA ENGLISH, MANUAL MODE 1/EA, Model Number: 21-2127-0104-01; 8) PUMP KIT, CADD-SOLIS VIP, MDL 2120, TRIAL/LOANER, NA ENGLISH, PHARMGUARD, 1/EA, Model Number: 21-2120-0105-00; 9) PUMP, CADD-SOLIS VIP, MDL 2120, TRIAL/LOANER CE GLOBAL ENGLISH 1/EA, Model Number: 21-2120-0103-78; 10) PUMP, CADD-SOLIS VIP, MDL 2120, ENGLISH, TRIAL/LOANER 1/EA, Model Number: 21-2120-0102-78; 11) PUMP, CADD-SOLIS VIP, MDL 2120, NFHU, NA ENGLISH, PHARMGUARD ENABLED 1/EA, Model Number: 21-2120-0104-231; 12) PUMP, CADD-SOLIS VIP, MDL 2120, ENGLISH, NFHU 1/EA, Model Number: 21-2120-0102-249; 13) PUMP, CADD-SOLIS VIP, MDL 2120, NFHU CE GLOBAL ENGLISH 1/EA, Model Number: 21-2120-0103-249; 14) PUMP KIT, CADD-SOLIS VIP, MDL 2120, NA ENGLISH, FACTORY LIBRARY 1/EA, Model Number: 21-2125-0104-01; 15) PUMP, CADD-SOLIS VIP, MDL 2120, ENGLISH, NFHU 1/EA, Model Number: 21-2120-0102-249.

Smiths Medical ASD

Class I - Dangerous

There is a potential for thermal damage in CADD-Solis and CADD- Solis VIP infusion pumps.

Apr 10, 2025 Infusion Pumps Nationwide View Details →