FDA Device recall Z-2609-2024

PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) NEONATAL TRACHEOSTOMY TUBE 2.5mm TTS FLEXTEND STRAIGHT FLANGE , Product Code/List…

FDA Device
Class I
ongoing
Published 2024-09-04

On 2024-09-04 the FDA classified a Class I recall of PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) NEONATAL TRACHEOSTOMY TUBE 2.5mm TTS FLEXTEND STRAIGHT FLANGE , Product Code/List… 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-2609-2024
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

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

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 10351688518774, NEONATAL TRACHEOSTOMY TUBE 2.5mm TTS FLEXTEND STRAIGHT FLANGE , Product Code/List Number/Item… 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,

code_info

a) UDI/DI 10351688518774, NEONATAL TRACHEOSTOMY TUBE 2.5mm TTS FLEXTEND STRAIGHT FLANGE , Product Code/List Number/Item…

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,

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-2609-2024%22

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