FDA Device Recall Z-2594-2024

Smiths Medical ASD Inc. · Minneapolis, MN

Class I — life-threatening Ongoing

Highest impact — Class I device recall — FDA determination that use of, or exposure to, the device will cause serious adverse health consequences or death.

Device

PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) 3.0MM FLEXTEND NEO STRAIGHT TRACH TUBE , Product Code/List Number/Item Code 60NFPS30; b) 3.5MM FLEXTEND NEO STRAIGHT TRACH TUBE , Product Code/List Number/Item Code 60NFPS35; c) 4.0MM FLEXTEND NEO STRAIGHT TRACH TUBE , Product Code/List Number/Item Code 60NFPS40

Lot / serial / GTIN: a) UDI/DI 15021312516685, Product Code/List Number/Item Code 60NFPS30, Lot Numbers: 3853441, 3868206, 3868207, 3871067, 3877651, 3887742, 3897854, 3904673, 3907995, 3926957, 3930007, 3939665, 3942472, 3946282, 3946283, 3955764, 3962605, 3982653, 3982654, 3988079, 4001201, 4008212, 4011376, 4018516, 4023788, 4029506, 4035731, 4048021, 4051634, 4053729, 4066288, 4077084, 4083942, 4092640, 4096832, 4105248, 4110445, 4122441, 4128014, 4138979, 4148025, 4159974, 4161993, 4168190, 4180503, 4185418, 4196272, 4209563, 4212773, 4218704, 4231493, 4233961, 4254232, 4276462, 4327915, 4334988, 4334989, 4345005, 4345006, 4351237, 4362840, 4369592, 4369593, 4374431, 4383622, 4389893, 4399165, 4400661; b) UDI/DI 15021312516692, Product Code/List Number/Item Code 60NFPS35, Lot Numbers: 3853442, 3868200, 3871058, 3877653, 3884262, 3887743, 3894902, 3904675, 3911432, 3918014, 3926968, 3942534, 3946286, 3952348, 3955767, 3982655, 3988080, 3988081, 3988082, 3991146, 3991147, 3991148, 3991149, 4008213, 4008214, 4011377, 4015538, 4026689, 4033719, 4041969, 4051659, 4051660, 4053738, 4060203, 4063180, 4071966, 4083934, 4083935, 4092635, 4097816, 4107610, 4119111, 4138997, 4151030, 4153610, 4159953, 4168147, 4173732, 4195805, 4196273, 4204815, 4206814, 4212774, 4217441, 4223727, 4231494, 4237379, 4240144, 4260066, 4276463, 4286800, 4327936, 4327937, 4331602, 4331604, 4334990, 4335052, 4351238, 4352783, 4353063, 4353086, 4374432, 4381013, 4381014, 4381015, 4383623, 4388158, 4388159, 4389894, 4399167, 4400664; c) UDI/DI 15021312516708; Product Code/List Number/Item Code 60NFPS40, Lot Numbers: 3853443, 3853444, 3868233, 3874303, 3887749, 3901298, 3907991, 3920946, 3933475, 3939636, 3949020, 3962567, 3982657, 3988089, 3988092, 3991150, 3991151, 4005639, 4008215, 4026668, 4053699, 4060217, 4083917, 4091394, 4110446, 4125819, 4145717, 4153576, 4161981, 4173733, 4196274, 4197613, 4204816, 4209564, 4217442, 4221341, 4231495, 4240145, 4254240, 4260067, 4276464, 4286801, 4327940, 4347202, 4362842, 4365799, 4388161, 4389895, 4395782, 4399168,

Quantity: 36219 units

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.

Recall record

Recall number: Z-2594-2024
Classification: Class I
Status: Ongoing
Voluntary or mandated: Voluntary: Firm initiated
Firm notification: Letter
Distribution: Worldwide distribution.
Recall initiated: 2024-05-29
Classified by FDA Center: 2024-08-23
FDA published: 2024-09-04
Recalling firm: Smiths Medical ASD Inc.
Firm location: Minneapolis, MN

Operational response

A Class I device recall indicates a strong likelihood of serious adverse health consequence or death from continued use. Identify affected units by serial number, lot, or GTIN against your inventory and against implanted-device patient registry. Pull affected inventory from active use immediately. For implanted devices, follow the recalling firm’s patient-notification protocol; in most cases this requires informing affected patients and their treating physicians directly.

For the official FDA enforcement record, see FDA's Recall Search.

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