Class 1 Device Recall Bivona AireCuf, TTS", FlexTend"

• Date Initiated by Firm: May 29, 2024
• Date Posted: August 23, 2024
• Recall Status: Open, Classified
• Recall Number: Z-2609-2024
• Recall Event ID: 94852
• 510(K)Number: K912469
• Product Classification: Tube, tracheostomy (w/wo connector) - Product Code BTO
• Product: PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) NEONATAL TRACHEOSTOMY TUBE 2.5mm TTS FLEXTEND STRAIGHT FLANGE , Product Code/List Number/Item Code 67NFPS25; b) NEONATAL TRACHEOSTOMY TUBE 3.0mm TTS FLEXTEND STRAIGHT FLANGE , Product Code/List Number/Item Code 67NFPS30; c) NEONATAL TRACHEOSTOMY TUBE 3.5mm TTS FLEXTEND STRAIGHT FLANGE , Product Code/List Number/Item Code 67NFPS35; d) NEONATAL TRACHEOSTOMY TUBE 4.0mm TTS FLEXTEND STRAIGHT FLANGE , Product Code/List Number/Item Code 67NFPS40
• Code Information: a) UDI/DI 10351688518774, NEONATAL TRACHEOSTOMY TUBE 2.5mm TTS FLEXTEND STRAIGHT FLANGE , Product Code/List Number/Item Code 67NFPS25, Lot Numbers: 3853382, 3880680, 3901286, 3918017, 3930028, 3952395, 3961751, 3997791, 4026686, 4038940, 4038941, 4096846, 4113104, 4136119, 4151050, 4159960, 4171573, 4179337, 4185402, 4218692, 4233740, 4327879, 4333978, 4333979, 4352758, 4372091, 4372092, 4372093, 4383596, 4388100, 4395738; b) UDI/DI 10351688518781, NEONATAL TRACHEOSTOMY TUBE 3.0mm TTS FLEXTEND STRAIGHT FLANGE , Product Code/List Number/Item Code 67NFPS30, Lot Numbers: 3853383, 3877674, 3884243, 3891517, 3901295, 3917994, 3930044, 3939657, 3942542, 3952413, 3952414, 3981972, 3981973, 3997792, 4001124, 4008198, 4018495, 4023776, 4029492, 4035686, 4035688, 4051670, 4060197, 4077103, 4080786, 4089289, 4095914, 4105262, 4107608, 4119105, 4125806, 4134038, 4142441, 4148024, 4156637, 4163848, 4173723, 4185404, 4213399, 4217430, 4254214, 4260047, 4273413, 4276443, 4286787, 4292152, 4322653, 4327895, 4329830, 4334222, 4344969, 4352759, 4369536, 4369537, 4369538, 4388102, 4395740, 4400623; c) UDI/DI 10351688518798, NEONATAL TRACHEOSTOMY TUBE 3.5mm TTS FLEXTEND STRAIGHT FLANGE , Product Code/List Number/Item Code 67NFPS35, Lot Numbers: 3853384, 3853385, 3868267, 3871038, 3880695, 3884238, 3891516, 3894911, 3904649, 3911417, 3926972, 3939651, 3942536, 3952411, 3959324, 3965911, 3981974, 3981975, 3997793, 3997794, 4011357, 4018496, 4023777, 4035689, 4035690, 4051622, 4053705, 4063162, 4066292, 4077075, 4086019, 4092642, 4097824, 4107604, 4110431, 4116106, 4125811, 4128038, 4134032, 4145682, 4147988, 4159958, 4168141, 4179338, 4216300, 4218693, 4237349, 4237350, 4240122, 4260048, 4260049, 4273412, 4276444, 4286788, 4322654, 4327908, 4329829, 4331558, 4334221, 4334225, 4334226, 4344970, 4348410, 4348411, 4357245, 4358489, 4358490, 4389868, 4389869, 4395741, 4399127, 4400625; d) UDI/DI 10351688518804, NEONATAL TRACHEOSTOMY TUBE 4.0mm TTS FLEXTEND STRAIGHT FLANGE , Product Code/List Number/Item Code 67NFPS40, Lot Numbers: 3884239, 3887729, 3894915, 3904650, 3936565, 3939648, 3939649, 3942543, 3946254, 3952409, 3962592, 3997795, 4001125, 4005580, 4011358, 4016058, 4026675, 4029493, 4035691, 4051669, 4060199, 4089292, 4119106, 4130998, 4145708, 4148020, 4163840, 4217431, 4237351, 4240123, 4276445, 4328209, 4334227, 4334228, 4352760, 4358476, 4362841, 4395743, 4399128
• Recalling Firm/ Manufacturer: Smiths Medical ASD Inc.; 6000 Nathan Ln N; Minneapolis MN 55442-1690
• For Additional Information Contact: Global Complaint Management; 866-216-8806
• Manufacturer 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.
• FDA Determined Cause: Under Investigation by firm
• Action: 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
• Distribution: Worldwide distribution.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.

• 510(K) Database: 510(K)s with Product Code = BTO