—#208971

Product

PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) 2.5mm TTS CUFFED NEONATAL TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 67SN025; b) 3.0mm TTS CUFFED NEONATAL TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 67SN030; c) 3.5mm TTS CUFFED NEONATAL TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 67SN035; d) 4.0mm TTS CUFFED NEONATAL TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 67SN040; e) 2.5mm TTS CUFFED PEDIATRIC TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 67SP025; f) 3.0mm TTS CUFFED PEDIATRIC TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 67SP030; g) 3.5mm TTS CUFFED PEDIATRIC TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 67SP035; h) 4.0mm TTS CUFFED PEDIATRIC TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 67SP040; i) 4.5mm TTS CUFFED PEDIATRIC TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 67SP045; j) 5.0mm TTS CUFFED PEDIATRIC TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 67SP050; k) 5.5mm TTS CUFFED PEDIATRIC TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 67SP055

FDA product code: BTO — Tube, Tracheostomy (W/Wo Connector)
Device class: Class 2
Medical specialty: Anesthesiology
510(k) numbers: K912469
Affected lot / code info: a) UDI/DI 15021312000238, Product Code/List Number/Item Code 67SN025, Lot Numbers: 3897849; 3936582; 4016050; 4119116; 4176209; 4328223; 4334976; 4352775; 4365802; b) UDI/DI 15021312000245, Product Code/List Number/Item Code 67SN030, Lot Numbers: 3868317, 3877644, 3897881, 3908000, 3965329, 3965330, 4080793, 4096827, 4122450, 4185412, 4283236, 4331589, 4334959, 4348425, 4353070, 4374420, 4399158; c) UDI/DI 15021312000252, Product Code/List Number/Item Code 67SN035, Lot Numbers: 3861151, 3887737, 3907993, 3923739, 3949041, 3965336, 4015535, 4016044, 4153588, 4185413, 4237375, 4328225, 4334960, 4348429, 4348430, 4381009, 4388146; d) UDI/DI 15021312000269, Product Code/List Number/Item Code 67SN040, Lot Numbers: 3861153, 3894898, 3923715, 3961255, 4016052, 4110442, 4130976, 4180472, 4328226, 4334961, 4365803; e) UDI/DI 15021312000665, Product Code/List Number/Item Code 67SP025, Lot Numbers: 3904678, 3961754, 4161974, 4328227, 4334962, 4352776, 4372095, 4388147, 4399160; f) UDI/DI¿15021312000696, Product Code/List Number/Item Code 67SP030, Lot Numbers: 3877648, 3897883, 3931152, 3942489, 3955804, 3962574, 4071972, 4075249, 4119088, 4159952, 4201369, 4254231, 4328228, 4331583, 4344992, 4374423, 4381010, 4388148, 4395775, 4400654; g) UDI/DI 15021312000719, Product Code/List Number/Item Code 67SP035, Lot Numbers: 3894891, 3901311, 3926976, 3942449, 3942450, 3942451, 3965920, 3982058, 3997809, 4012664, 4051662, 4066294, 4077067, 4086030, 4119122, 4125830, 4147982, 4153606, 4163818, 4180462, 4204811, 4213415, 4240139, 4289477, 4322669, 4327927, 4331584, 4334963, 4348433, 4352779, 4362880, 4369585, 4369586, 4369587, 4400655; h) UDI/DI 15021312000726, Product Code/List Number/Item Code 67SP040, Lot Numbers: 3853432, 3871054, 3880706, 3891531, 3897862, 3907985, 3920947, 3926962, 3942485, 3952370, 3952371, 3987968, 3997810, 3997811, 4011374, 4021420, 4029503, 4048008, 4053717, 4071971, 4075250, 4086005, 4095920, 4125817, 4142423, 4148029, 4153614, 4159936, 4168140, 4185414, 4217439, 4221339, 4237376, 4286797, 4328229, 4331585, 4331586, 4334965, 4344993, 4348439, 4348441, 4362885, 4365804, 4380079; i) UDI/DI 15021312000733, Product Code/List Number/Item Code 67SP045, Lot Numbers: 3853433, 3864230, 3871065, 3877649, 3887752, 3897884, 3908002, 3917995, 3926965, 3946265, 3952356, 3965905, 3987969, 3997812, 4011375, 4018513, 4029504, 4043932, 4051648, 4053737, 4063179, 4071973, 4075251, 4086028, 4086029, 4110444, 4128011, 4139009, 4151021, 4156654, 4168143, 4176203, 4185415, 4196270, 4201371, 4237377, 4240140, 4247289, 4273424, 4286798, 4289478, 4328230, 4331587, 4334966, 4344994, 4348442, 4348443, 4353071, 4365805, 4399161; j) UDI/DI 15021312000740, Product Code/List Number/Item Code 67SP050, Lot Numbers: 3853435, 3853436, 3874295, 3891534, 3907988, 3920939, 3920940, 3926982, 3942469, 3949040, 3959338, 3962595, 3982061, 3997813, 4008207, 4018514, 4026695, 4028692, 4028710, 4077096, 4086009, 4100883, 4113099, 4125808, 4134025, 4142418, 4151038, 4156617, 4161973, 4171585, 4179352, 4185416, 4204812, 4213416, 4221340, 4247290, 4286799, 4322670, 4327922, 4328231, 4331588, 4334967, 4344995, 4348453, 4348454, 4348455, 4353081, 4353478, 4369588, 4369589, 4388149, 4395776, 4400656; k) UDI/DI 15021312000757, Product Code/List Number/Item Code 67SP055, Lot Numbers: 3874309, 3884258, 3887753, 3894900, 3897882, 3911438, 3926963, 3941951, 3946266, 3949044, 3955803, 3965906, 3982062, 3997814, 4015536, 4026669, 4026670, 4033717, 4035727, 4048019, 4053736, 4077081, 4091409, 4100897, 4113117, 4125828, 4136136, 4145696, 4153602, 4159989, 4163849, 4173729, 4185417, 4201372, 4213417, 4231490, 4247291, 4289479, 4322671, 4327888, 4328232, 4328233, 4334968, 4334969, 4344342, 4348457, 4374424, 4383620, 4388150, 4388151, 4395777, 4400657

Why it was recalled

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.

Root cause (FDA determination)

Under Investigation by firm

Action the firm took

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

Recalling firm

Firm: Smiths Medical ASD Inc.
Address: 6000 Nathan Ln N, Minneapolis, Minnesota 55442-1690

Distribution

Distribution pattern: Worldwide distribution.

Timeline

Recall initiated: 2024-05-29
Posted by FDA: 2024-08-23
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #208971. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.