Smiths Medical ASD Inc.: PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) PAED. TRACHEOSTOMY TUBE 2.5MM STANDARD FLEXTEND PLUS , Product Code/List Number/Item Code 60PFS25; b) PAED. TRACHEOSTOMY TUBE 3.0MM STANDARD FLEXTEND PLUS , Product Code/List Number/Item Code 60PFS30; c) PAED. TRACHEOSTOMY TUBE 3.5MM STANDARD FLEXTEND PLUS , Product Code/List Number/Item Code 60PFS35; d) PAED. TRACHEOSTOMY TUBE 4.0MM STANDARD FLEXTEND PLUS , Product Code/List Number/Item Code 60PFS40; e) PAED. TRACHEOSTOMY TUBE 4.5MM STANDARD FLEXTEND PLUS , Product Code/List Number/Item Code 60PFS45; f) PAED. TRACHEOSTOMY TUBE 5.0MM STANDARD FLEXTEND PLUS , Product Code/List Number/Item Code 60PFS50; g) PAED. TRACHEOSTOMY TUBE 5.5MM STANDARD FLEXTEND PLUS , Product Code/List Number/Item Code 60PFS55

Recall number

Z-2599-2024

Recalling firm

Smiths Medical ASD Inc.

Product

PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) PAED. TRACHEOSTOMY TUBE 2.5MM STANDARD FLEXTEND PLUS , Product Code/List Number/Item Code 60PFS25; b) PAED. TRACHEOSTOMY TUBE 3.0MM STANDARD FLEXTEND PLUS , Product Code/List Number/Item Code 60PFS30; c) PAED. TRACHEOSTOMY TUBE 3.5MM STANDARD FLEXTEND PLUS , Product Code/List Number/Item Code 60PFS35; d) PAED. TRACHEOSTOMY TUBE 4.0MM STANDARD FLEXTEND PLUS , Product Code/List Number/Item Code 60PFS40; e) PAED. TRACHEOSTOMY TUBE 4.5MM STANDARD FLEXTEND PLUS , Product Code/List Number/Item Code 60PFS45; f) PAED. TRACHEOSTOMY TUBE 5.0MM STANDARD FLEXTEND PLUS , Product Code/List Number/Item Code 60PFS50; g) PAED. TRACHEOSTOMY TUBE 5.5MM STANDARD FLEXTEND PLUS , Product Code/List Number/Item Code 60PFS55

Status

Open, Classified

Initiated

2024-05-29

Posted

2024-08-23

Terminated

not on file

Reason

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

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

Quantity

not on file

Distribution

Worldwide distribution.

Lot, serial or model codes

a) UDI/DI 15021312005837, Product Code/List Number/Item Code 60PFS25, Lot Numbers: 3868288, 3901288, 3917984, 3942491, 3952376, 3988093, 4015545, 4075235, 4086043, 4196278, 4216321, 4335004, 4348474; b) UDI/DI15021312005844, Product Code/List Number/Item Code 60PFS30, Lot Numbers: 3853454, 3868300, 3871052, 3884251, 3907992, 3939630, 3952417, 3955789, 3962601, 3965922, 3982669, 3982670, 3991157, 4005649, 4005650, 4018519, 4029510, 4035742, 4048015, 4051632, 4066295, 4077078, 4080801, 4086025, 4092648, 4097834, 4110453, 4119110, 4131005, 4136139, 4148028, 4159992, 4171551, 4176201, 4180492, 4185419, 4201383, 4206818, 4216322, 4221344, 4273425, 4276465, 4283239, 4292166, 4335005, 4345011, 4351239, 4374438, 4374439, 4374440, 4381017, 4383626, 4388167, 4388168, 4389899, 4393409, 4399180, 4400668; c) UDI/DI 15021312005851, Product Code/List Number/Item Code 60PFS35, Lot Numbers: 3840084, 3843107, 3853456, 3853457, 3853458, 3858172, 3868320, 3874291, 3874292, 3874293, 3874294, 3880702, 3884241, 3887745, 3891532, 3901293, 3904667, 3907987, 3917981, 3920937, 3920938, 3930041, 3936575, 3942465, 3942466, 3942467, 3942468, 3946228, 3946229, 3946230, 3946231, 3955802, 3962598, 3962599, 3982671, 3982672, 3988094, 3988095, 3988096, 3988097, 3991159, 3991160, 3991161, 3991162, 4005651, 4005654, 4008218, 4008219, 4015546, 4015547, 4021418, 4026694, 4033724, 4035743, 4048010, 4051625, 4053720, 4056230, 4060212, 4060213, 4063185, 4071981, 4075241, 4083914, 4089301, 4092633, 4097833, 4105259, 4107594, 4110454, 4116094, 4122438, 4128018, 4130990, 4134027, 4145710, 4148001, 4151036, 4153618, 4156615, 4159944, 4163822, 4163823, 4176221, 4179357, 4185420, 4196279, 4197615, 4201384, 4204817, 4206819, 4209565, 4216323, 4217444, 4218707, 4221345, 4223730, 4231501, 4233963, 4233964, 4240150, 4254247, 4260068, 4273426, 4279333, 4283240, 4286802, 4289480, 4292167, 4292168, 4331613, 4331614, 4335008, 4335009, 4335010, 4335011, 4345012, 4352785, 4352786, 4360406, 4360407, 4360408, 4369596, 4369598, 4374441, 4374442, 4374443, 4381018, 4381019, 4381020, 4383627, 4383628, 4383632, 4388169, 4388170, 4388171, 4388172, 4393410; d) UDI/DI 15021312005868, Product Code/List Number/Item Code 60PFS40, Lot Numbers: 3835740, 3868304, 3868305, 3868306, 3868307, 3868309, 3868310, 3868311, 3871061, 3880721, 3880722, 3884259, 3887731, 3894886, 3894887, 3897887, 3901308, 3907996, 3907997, 3918003, 3920955, 3942503, 3942504, 3942505, 3942506, 3946268, 3946269, 3946270, 3955782, 3955783, 3955784, 3955785, 3959304, 3959305, 3962576, 3982674, 3982679, 3982680, 3982683, 3988100, 3988101, 3988102, 3991164, 3991165, 3991166, 3991167, 3991168, 4005655, 4005656, 4005662, 4005664, 4005665, 4005666, 4015548, 4015549, 4015550, 4033725, 4048022, 4051650, 4051651, 4053718, 4056236, 4056237, 4063186, 4063187, 4071985, 4071986, 4075242, 4077110, 4080791, 4089309, 4093736, 4107572, 4107573, 4113115, 4119101, 4122448, 4128031, 4139013, 4145719, 4151013, 4153596, 4159975, 4161991, 4163834, 4171552, 4176239, 4179358, 4180464, 4185421, 4185422, 4185423, 4204818, 4206820, 4209566, 4209567, 4212780, 4216324, 4218708, 4221346, 4231502, 4233965, 4233967, 4234639, 4237385, 4240151, 4254248, 4260069, 4273427, 4279334, 4283241, 4286803, 4286804, 4289481, 4289482, 4292169, 4292170, 4322675, 4331615, 4335012, 4335013, 4335014, 4345013, 4345014, 4348476, 4348477, 4351240, 4355431, 4355432, 4357235, 4357236, 4357237, 4358510, 4365777, 4369600, 4379950, 4379960, 4381021, 4383629, 4383630, 4383631, 4388173, 4388174, 4388175, 4389901, 4389902, 4399188; e) UDI/DI 15021312005875, Product Code/List Number/Item Code 60PFS45, Lot Numbers: 3843109, 3853462, 3868224, 3871045, 3877666, 3884240, 3887744, 3894868, 3901292, 3907986, 3920936, 3923717, 3931141, 3939634, 3942458, 3942459, 3942460, 3949039, 3955799, 3955800, 3955801, 3962597, 3982681, 3982682, 3988103, 3988104, 3988105, 3988106, 3991169, 3991170, 3991171, 3991172, 4015552, 4015553, 4015556, 4015557, 4018520, 4033726, 4035745, 4051624, 4053731, 4060211, 4071980, 4083912, 4093737, 4105258, 4107600, 4113105, 4122436, 4136141, 4148002, 4156616, 4163820, 4179359, 4185424, 4196280, 4197617, 4209568, 4212781, 4216325, 4217445, 4223731, 4231504, 4237386, 4240152, 4254249, 4276466, 4279335, 4283242, 4289483, 4289484, 4292172, 4322676, 4335015, 4335016, 4345015, 4347208, 4351241, 4353064, 4353095, 4374444, 4374445, 4374446, 4379941, 4381022, 4383633, 4383634, 4388176, 4388177, 4388178, 4388179, 4389903, 4395789; f) UDI/DI 15021312005882, Product Code/List Number/Item Code 60PFS50, Lot Numbers: 3840085, 3868297, 3868298, 3868299, 3877642, 3884250, 3894889, 3897872, 3911431, 3920969, 3939629, 3942455, 3946245, 3949028, 3955787, 3955788, 3962600, 3982684, 3988108, 3988109, 3988110, 3991174, 3991175, 3991176, 3997817, 3997828, 4015558, 4018521, 4018522, 4029511, 4051631, 4060227, 4071969, 4083931, 4096826, 4100896, 4110455, 4122443, 4128043, 4145694, 4153587, 4159976, 4168142, 4171553, 4180498, 4204819, 4206821, 4212782, 4217446, 4218709, 4221347, 4233968, 4254252, 4279336, 4283243, 4286805, 4289485, 4292173, 4335017, 4335018, 4345016, 4345017, 4352788, 4365778, 4366203, 4369601, 4369602, 4374447, 4374448, 4381023, 4383635, 4388180, 4388181, 4389904, 4395790, 4399191; g) UDI/DI 15021312005899, Product Code/List Number/Item Code 60PFS55, Lot Numbers: 3853464, 3868208, 3868209, 3877656, 3877657, 3884235, 3901309, 3911422, 3930034, 3930035, 3930036, 3930037, 3936573, 3939625, 3950394, 3982685, 3988111, 3988112, 3991177, 3991178, 3991179, 3997818, 3997829, 4033727, 4035746, 4053735, 4063188, 4083938, 4105250, 4110456, 4122426, 4128035, 4148016, 4163837, 4179360, 4180173, 4204820, 4209569, 4233969, 4276467, 4283244, 4289486, 4322677, 4335020, 4335021, 4352789, 4362868, 4369603, 4369604, 4374449, 4383636, 4388182, 4389905, 4395791, 4399192

510(k) numbers

["K912469"]

PMA numbers

not on file

Product code

BTO

Firm FEI

3012307300

Firm city

Minneapolis

Firm state

MN

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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