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
This recall is currently active, issued August 23, 2024. It was issued by Smiths Medical Asd Inc..
- Company
- Smiths Medical Asd Inc.
- Recall Initiated
- May 29, 2024
- Posted
- August 23, 2024
- Recall Number
- Z-2610-2024
- Firm Location
- Minneapolis, MN
- Official Source
- View on FDA website ↗
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.
Distribution
Worldwide distribution.
Lot / Code Info
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
Root Cause
Under Investigation by firm
Action Taken
Smiths Medical issued an URGENT MEDICAL DEVICE NOTIFICATION to its consignees on 05/29/2024 via letter. The notice explained the issue with the device, potential risk and requested the following: "Customer Required Actions: When using the device, all instructions, including warning and cautions contained in the Instructions for Use Documentation must be followed with heightened awareness. Please complete the following actions listed below: 1. Check all inventory locations within your institution for the affected catalog numbers listed in the notification and discontinue use. Discard all affected products following your institution s process for discarding. If discarding is not immediately possible at your facility, then the product should be quarantined until disposal. 2. Share this notification with all potential users of the devices to ensure they are aware of this notification and proposed mitigations. If the devices are used at another location, please ensure this communication is delivered there. 3. Complete and return the attached Customer Response Form to smithsmedical3513@sedgwick.com within 10 days of receipt to acknowledge your understanding of this notification. Please contact your local representative for assistance with replacement product and/or credit. 3. DISTRIBUTORS: If you have distributed potentially affected products to your customers, please immediately forward this notice to them. Request that they complete the response form and return it to smithsmedical3513@sedgwick.com" Questions: Global Complaint Management - 1-(866)-216-8806 or US: globalcomplaints@icumed.com Customer Service: Customerservice@icumed.com or 1-(800)-258-5361