FDA Device recall Z-2610-2024

PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) TTS PEDIATRIC TRACH TUBE , Product Code/List Number/Item Code 67P025

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) TTS PEDIATRIC TRACH TUBE , Product Code/List Number/Item Code 67P025 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-2610-2024
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) TTS PEDIATRIC TRACH TUBE , Product Code/List Number/Item Code 67P025; b) TTS PEDIATRIC TRACH TUBE , Product Code/List Number/Item Code 67P030; c) TTS PEDIATRIC TRACH TUBE , Product Code/List Number/Item Code 67P035; d) TTS PEDIATRIC TRACH TUBE , Product Code/List Number/Item Code 67P040; e) TTS PEDIATRIC TRACH TUBE, Product Code/List Number/Item Code 67P045; f) TTS PEDIATRIC TRACH TUBE, Product Code/List Number/Item Code 67P050; g) TTS PEDIATRIC TRACH TUBE, Product Code/List Number/Item Code 67P055

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 15021312006247, Product Code/List Number/Item Code 67P025, Lot Numbers: 3880708, 3942483, 3961750, 4125814,… a) UDI/DI 15021312006247, Product Code/List Number/Item Code 67P025, Lot Numbers: 3880708, 3942483, 3961750, 4125814, 4179339, 4331560, 4352761, 4374403, 4388103, 4395744; b) UDI/DI 15021312006254, Product Code/List Number/Item Code 67P030, Lot Numbers: 3853386, 3871064, 3880713, 3891523, 3901304, 3926964, 3939647, 3946264, 3949043, 3997796, 4015526, 4048024, 4051646, 4063163, 4080781, 4089294, 4110432, 4125827, 4150020, 4168144, 4185405, 4218694, 4260051, 4279318, 4328210, 4334884, 4344971, 4374404, 4374405, 4383597, 4388104, 4395745, 4400626; c) UDI/DI 15021312006261, Product Code/List Number/Item Code 67P035, Lot Numbers: 3853387, 3874306, 3880716, 3894885, 3907998, 3931149, 3939662, 3942508, 3942509, 3981976, 3981978, 3997797, 4011359, 4012663, 4026682, 4051652, 4063164, 4080789, 4086022, 4095912, 4100887, 4119100, 4128030, 4136120, 4145720, 4148011, 4153597, 4156651, 4168178, 4180451, 4213400, 4221332, 4240124, 4260052, 4273414, 4279319, 4286789, 4292153, 4322655, 4327931, 4

code_info

a) UDI/DI 15021312006247, Product Code/List Number/Item Code 67P025, Lot Numbers: 3880708, 3942483, 3961750, 4125814,…

a) UDI/DI 15021312006247, Product Code/List Number/Item Code 67P025, Lot Numbers: 3880708, 3942483, 3961750, 4125814, 4179339, 4331560, 4352761, 4374403, 4388103, 4395744; b) UDI/DI 15021312006254, Product Code/List Number/Item Code 67P030, Lot Numbers: 3853386, 3871064, 3880713, 3891523, 3901304, 3926964, 3939647, 3946264, 3949043, 3997796, 4015526, 4048024, 4051646, 4063163, 4080781, 4089294, 4110432, 4125827, 4150020, 4168144, 4185405, 4218694, 4260051, 4279318, 4328210, 4334884, 4344971, 4374404, 4374405, 4383597, 4388104, 4395745, 4400626; c) UDI/DI 15021312006261, Product Code/List Number/Item Code 67P035, Lot Numbers: 3853387, 3874306, 3880716, 3894885, 3907998, 3931149, 3939662, 3942508, 3942509, 3981976, 3981978, 3997797, 4011359, 4012663, 4026682, 4051652, 4063164, 4080789, 4086022, 4095912, 4100887, 4119100, 4128030, 4136120, 4145720, 4148011, 4153597, 4156651, 4168178, 4180451, 4213400, 4221332, 4240124, 4260052, 4273414, 4279319, 4286789, 4292153, 4322655, 4327931, 4

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-2610-2024%22

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