FDA Device recall Z-2614-2024

a) PEDIATRIC TRACHEOSTOMY TUBE 2.5mm TTS FLEXTEND STRAIGHT NECK , Product Code/List Number/Item Code 67PFSS25

FDA Device
Class I
ongoing
Published 2024-09-04

On 2024-09-04 the FDA classified a Class I recall of a) PEDIATRIC TRACHEOSTOMY TUBE 2.5mm TTS FLEXTEND STRAIGHT NECK , Product Code/List Number/Item Code 67PFSS25 by Smiths Medical Asd, citing 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 defe….

Read the official FDA Device notice

Agency	FDA Device
Recall number	Z-2614-2024
Classification	Class I
Status	ongoing
Initiated	2024-05-29
Published	2024-09-04
Last updated	2026-09-13 11:57 UTC
Company	Smiths Medical Asd
Distribution	n/a

Product

a) PEDIATRIC TRACHEOSTOMY TUBE 2.5mm TTS FLEXTEND STRAIGHT NECK , Product Code/List Number/Item Code 67PFSS25; b) PEDIATRIC TRACHEOSTOMY TUBE 3.0mm TTS FLEXTEND STRAIGHT NECK , Product Code/List Number/Item Code 67PFSS30; c) PEDIATRIC TRACHEOSTOMY TUBE 3.5mm TTS FLEXTEND STRAIGHT NECK , Product Code/List Number/Item Code 67PFSS35; d) PEDIATRIC TRACHEOSTOMY TUBE 4.0mm TTS FLEXTEND STRAIGHT NECK , Product Code/List Number/Item Code 67PFSS40; e) PEDIATRIC TRACHEOSTOMY TUBE 4.5mm TTS FLEXTEND STRAIGHT NECK , Product Code/List Number/Item Code 67PFSS45; f) PEDIATRIC TRACHEOSTOMY TUBE 5.0mm TTS FLEXTEND STRAIGHT NECK , Product Code/List Number/Item Code 67PFSS50; g) PEDIATRIC TRACHEOSTOMY TUBE 5.5mm TTS FLEXTEND STRAIGHT NECK , Product Code/List Number/Item Code 67PFSS55

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.

Identifiers

code_info	a) UDI/DI 10351688518668, Product Code/List Number/Item Code 67PFSS25, Lot Numbers: 3897874, 3911416, 3923743, 4005596… a) UDI/DI 10351688518668, Product Code/List Number/Item Code 67PFSS25, Lot Numbers: 3897874, 3911416, 3923743, 4005596, 4016053, 4016057, 4080314, 4087038, 4217435, 4327880, 4334932, 4374412, 4381000; b) UDI/DI 10351688518675, Product Code/List Number/Item Code 67PFSS30, Lot Numbers: 3853409, 3853410, 3868326, 3871053, 3877650, 3887740, 3897845, 3923723, 3931154, 3939667, 3939668, 3946281, 3959294, 3961757, 3961758, 3981997, 3981998, 3987959, 3991133, 4005597, 4011365, 4035710, 4051637, 4051638, 4063173, 4071984, 4075246, 4089295, 4095916, 4096830, 4110438, 4116085, 4136131, 4138990, 4156656, 4159994, 4171580, 4171581, 4185411, 4195802, 4212764, 4217436, 4233952, 4254222, 4273418, 4276453, 4276454, 4279325, 4292159, 4322660, 4322661, 4327910, 4329839, 4334936, 4344353, 4344980, 4344981, 4348422, 4357249, 4357250, 4358491, 4358492, 4374413, 4380076, 4381001, 4383608, 4388128, 4388129, 4388130, 4389879, 4393395, 4395763, 4399143; c) UDI/DI 10351688518682, Product Code/List Number/Ite

code_info

a) UDI/DI 10351688518668, Product Code/List Number/Item Code 67PFSS25, Lot Numbers: 3897874, 3911416, 3923743, 4005596…

a) UDI/DI 10351688518668, Product Code/List Number/Item Code 67PFSS25, Lot Numbers: 3897874, 3911416, 3923743, 4005596, 4016053, 4016057, 4080314, 4087038, 4217435, 4327880, 4334932, 4374412, 4381000; b) UDI/DI 10351688518675, Product Code/List Number/Item Code 67PFSS30, Lot Numbers: 3853409, 3853410, 3868326, 3871053, 3877650, 3887740, 3897845, 3923723, 3931154, 3939667, 3939668, 3946281, 3959294, 3961757, 3961758, 3981997, 3981998, 3987959, 3991133, 4005597, 4011365, 4035710, 4051637, 4051638, 4063173, 4071984, 4075246, 4089295, 4095916, 4096830, 4110438, 4116085, 4136131, 4138990, 4156656, 4159994, 4171580, 4171581, 4185411, 4195802, 4212764, 4217436, 4233952, 4254222, 4273418, 4276453, 4276454, 4279325, 4292159, 4322660, 4322661, 4327910, 4329839, 4334936, 4344353, 4344980, 4344981, 4348422, 4357249, 4357250, 4358491, 4358492, 4374413, 4380076, 4381001, 4383608, 4388128, 4388129, 4388130, 4389879, 4393395, 4395763, 4399143; c) UDI/DI 10351688518682, Product Code/List Number/Ite

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2614-2024%22

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