FDA Device recall Z-2589-2024

PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) AIRE-CUF TRACHY TUBE 6.0MM MID-RANGE , Product Code/List Number/Item Code 750160

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) AIRE-CUF TRACHY TUBE 6.0MM MID-RANGE , Product Code/List Number/Item Code 750160 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-2589-2024
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) AIRE-CUF TRACHY TUBE 6.0MM MID-RANGE , Product Code/List Number/Item Code 750160; b) AIRE-CUF TRACHY TUBE 7.0MM MID-RANGE , Product Code/List Number/Item Code 750170; c) AIRE-CUF TRACHY TUBE 8.0MM MID-RANGE , Product Code/List Number/Item Code 750180

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 15021312006407, Product Code/List Number/Item Code 750160, lot Numbers: 3790021, 3797124, 3797136, 3797137,… a) UDI/DI 15021312006407, Product Code/List Number/Item Code 750160, lot Numbers: 3790021, 3797124, 3797136, 3797137, 3800590, 3801380, 3801381, 3827984, 3827985, 3827986, 3839579, 3845047, 3889987, 3889988, 3889989, 3889990, 3889991, 3889992, 3897746, 3901189, 3904496, 3907895, 3935853, 3939484, 3939485, 3948992, 3952199, 3959207, 3962464, 3984937, 3988245, 3988246, 4002287, 4015646, 4021436, 4023799, 4029461, 4035831, 4042010, 4048004, 4054475, 4077142, 4089240, 4101026, 4112458, 4122498, 4128115, 4131096, 4136212, 4142486, 4145818, 4148087, 4156756, 4168094, 4176332, 4191370, 4192838, 4192839, 4192840, 4197660, 4205253, 4216365, 4229363, 4229364, 4257858, 4263227, 4276390, 4335536, 4362636, 4371677, 4390912, 4391730, 4391731, 4401458; b) UDI/DI 15021312006414, Product Code/List Number/Item Code 750170, lot Numbers: 3790106, 3790107, 3790108, 3790109, 3790110, 3790111, 3790112, 3790113, 3801538, 3828066, 3828067, 3828068, 3828069, 3828070, 3828071, 3839569, 3839570, 3839571, 38395

code_info

a) UDI/DI 15021312006407, Product Code/List Number/Item Code 750160, lot Numbers: 3790021, 3797124, 3797136, 3797137,…

a) UDI/DI 15021312006407, Product Code/List Number/Item Code 750160, lot Numbers: 3790021, 3797124, 3797136, 3797137, 3800590, 3801380, 3801381, 3827984, 3827985, 3827986, 3839579, 3845047, 3889987, 3889988, 3889989, 3889990, 3889991, 3889992, 3897746, 3901189, 3904496, 3907895, 3935853, 3939484, 3939485, 3948992, 3952199, 3959207, 3962464, 3984937, 3988245, 3988246, 4002287, 4015646, 4021436, 4023799, 4029461, 4035831, 4042010, 4048004, 4054475, 4077142, 4089240, 4101026, 4112458, 4122498, 4128115, 4131096, 4136212, 4142486, 4145818, 4148087, 4156756, 4168094, 4176332, 4191370, 4192838, 4192839, 4192840, 4197660, 4205253, 4216365, 4229363, 4229364, 4257858, 4263227, 4276390, 4335536, 4362636, 4371677, 4390912, 4391730, 4391731, 4401458; b) UDI/DI 15021312006414, Product Code/List Number/Item Code 750170, lot Numbers: 3790106, 3790107, 3790108, 3790109, 3790110, 3790111, 3790112, 3790113, 3801538, 3828066, 3828067, 3828068, 3828069, 3828070, 3828071, 3839569, 3839570, 3839571, 38395

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-2589-2024%22

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