Z-2610-2024 Class I Ongoing

PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) TTS PEDIATRIC TRACH TUBE , Product Code/List Number/Item Code 67P025; b) TTS PEDIATRIC TRACH TUBE , Product Code/List Number/Item Code 67P030; c) TTS PEDIATRIC TRACH TUBE , Product Code/List Number/Item Code 67P035; d) TTS PEDIATRIC TRACH TUBE , Product Code/List Number/Item Code 67P040; e) TTS PEDIATRIC TRACH TUBE, Product Code/List Number/Item Code 67P045; f) TTS PEDIATRIC TRACH TUBE, Product Code/List Number/Item Code 67P050; g) TTS PEDIATRIC TRACH TUBE, Product Code/List Number/Item Code 67P055

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.

a) UDI/DI 15021312006247, Product Code/List Number/Item Code 67P025, Lot Numbers: 3880708, 3942483, 3961750, 4125814, 4179339, 4331560, 4352761, 4374403, 4388103, 4395744; b) UDI/DI 15021312006254, Product Code/List Number/Item Code 67P030, Lot Numbers: 3853386, 3871064, 3880713, 3891523, 3901304, 3926964, 3939647, 3946264, 3949043, 3997796, 4015526, 4048024, 4051646, 4063163, 4080781, 4089294, 4110432, 4125827, 4150020, 4168144, 4185405, 4218694, 4260051, 4279318, 4328210, 4334884, 4344971, 4374404, 4374405, 4383597, 4388104, 4395745, 4400626; c) UDI/DI 15021312006261, Product Code/List Number/Item Code 67P035, Lot Numbers: 3853387, 3874306, 3880716, 3894885, 3907998, 3931149, 3939662, 3942508, 3942509, 3981976, 3981978, 3997797, 4011359, 4012663, 4026682, 4051652, 4063164, 4080789, 4086022, 4095912, 4100887, 4119100, 4128030, 4136120, 4145720, 4148011, 4153597, 4156651, 4168178, 4180451, 4213400, 4221332, 4240124, 4260052, 4273414, 4279319, 4286789, 4292153, 4322655, 4327931, 4331561, 4334885, 4334886, 4362876, 4362877, 4362878, 4369529, 4380069, 4395746, 4399129; d) UDI/DI 15021312006278, Product Code/List Number/Item Code 67P040, Lot Numbers: 3853388, 3880696, 3897851, 3901312, 3918020, 3926977, 3936572, 3942448, 3946287, 3955806, 3965921, 3981977, 3997798, 4005579, 4011360, 4033702, 4051617, 4056238, 4060202, 4077065, 4083937, 4086033, 4097825, 4110433, 4110443, 4122425, 4136121, 4145676, 4159986, 4161956, 4207455, 4216304, 4221333, 4273415, 4276446, 4286790, 4292155, 4327926, 4331562, 4334887, 4334888, 4344973, 4352762, 4353077, 4358512, 4358514, 4362884, 4365801, 4369541, 4383598, 4388105, 4389870, 4393389, 4399130, 4400627; e) UDI/DI 15021312006285, Product Code/List Number/Item Code 67P045, Lot Numbers: 3853389, 3853390, 3874307, 3880718, 3887718, 3897880, 3918004, 3923734, 3939663, 3939664, 3945817, 3946275, 3946276, 3955778, 3959301, 3981983, 3997799, 3997800, 4015527, 4015528, 4026676, 4035692, 4051653, 4058122, 4063165, 4077112, 4091402, 4107574, 4122449, 4131003, 4151016, 4159971, 4180452, 4213401, 4216302, 4218695, 4221334, 4234642, 4240125, 4260054, 4273416, 4276447, 4279320, 4328211, 4331563, 4334889, 4334890, 4348413, 4353068, 4353069, 4369547, 4369549, 4369551, 4369553, 4369554, 4380070, 4399131, 4400628; f) UDI/DI 15021312006292, Product Code/List Number/Item Code 67P050, Lot Numbers: 3802119, 3853391, 3853392, 3874290, 3887747, 3891533, 3894867, 3901290, 3904665, 3917980, 3923719, 3923720, 3939633, 3942464, 3949036, 3949037, 3949038, 3955793, 3959337, 3965923, 3981979, 3991126, 4005585, 4009522, 4018498, 4033703, 4048028, 4053732, 4060210, 4077095, 4083915, 4086008, 4107595, 4116096, 4128019, 4142417, 4153616, 4156614, 4159943, 4168157, 4171574, 4179340, 4197604, 4217432, 4237352, 4273417, 4286791, 4292156, 4322656, 4327925, 4328212, 4331564, 4331565, 4331566, 4334891, 4344974, 4344975, 4352766, 4353078, 4369531, 4383599, 4388106, 4388107, 4389871, 4395747, 4399132; g) UDI/DI 15021312006308, Product Code/List Number/Item Code 67P055, Lot Numbers: 3853393, 3868203, 3868205, 3880703, 3887738, 3894896, 3897852, 3907994, 3918007, 3926983, 3936569, 3939661, 3942457, 3949050, 3955819, 3962602, 3981980, 3987939, 3987940, 3997801, 4001126, 4005586, 4008199, 4018499, 4018500, 4035693, 4048017, 4051630, 4056240, 4063167, 4071111, 4077082, 4083941, 4085996, 4092638, 4096831, 4105246, 4107570, 4116086, 4119120, 4130986, 4136122, 4142454, 4151009, 4156649, 4159970, 4161989, 4171575, 4185406, 4207454, 4213402, 4233738, 4237353, 4286792, 4322657, 4327918, 4327919, 4331567, 4334893, 4334894, 4344337, 4351223, 4352767, 4374406, 4374407, 4380071, 4380072, 4380073, 4383600, 4388108, 4388109, 4388110, 4393390, 4400629