FDA Device recall Z-2601-2024

PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) 3.0MM FLEXTEND PEDIATRIC STANDARD STRAIGHT TRACH TUBE , Product Code/List Number/I…

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) 3.0MM FLEXTEND PEDIATRIC STANDARD STRAIGHT TRACH TUBE , Product Code/List Number/I… 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-2601-2024
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) 3.0MM FLEXTEND PEDIATRIC STANDARD STRAIGHT TRACH TUBE , Product Code/List Number/Item Code 60PFSS30; b) 3.5MM FLEXTEND PEDIATRIC STANDARD STRAIGHT TRACH TUBE , Product Code/List Number/Item Code 60PFSS35; c) 4.0MM FLEXTEND PEDIATRIC STANDARD STRAIGHT TRACH TUBE TRACH TUBE , Product Code/List Number/Item Code 60PFSS40; d) 4.5MM FLEXTEND PEDIATRIC STANDARD STRAIGHT TRACH TUBE , Product Code/List Number/Item Code 60PFSS45; e) 5.0MM FLEXTEND PEDIATRIC STANDARD STRAIGHT TRACH TUBE , Product Code/List Number/Item Code 60PFSS50; f) 5.5MM FLEXTEND PEDIATRIC STANDARD STRAIGHT TRACH TUBE , Product Code/List Number/Item Code 60PFSS55

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 15021312516760, Product Code/List Number/Item Code 60PFSS30, Lot Numbers: 3868215, 3868216, 3868217, 3868218… a) UDI/DI 15021312516760, Product Code/List Number/Item Code 60PFSS30, Lot Numbers: 3868215, 3868216, 3868217, 3868218, 3874311, 3880720, 3887755, 3894894, 3904669, 3907971, 3917982, 3926967, 3933476, 3939635, 3942492, 3946278, 3946279, 3946280, 3962580, 3982686, 3988113, 3991183, 4001204, 4011379, 4011380, 4015559, 4029512, 4033728, 4033729, 4040575, 4048009, 4053713, 4060206, 4070853, 4077071, 4077072, 4083908, 4091412, 4096836, 4105256, 4110458, 4113107, 4119118, 4128037, 4130977, 4134021, 4142421, 4145693, 4151047, 4156612, 4159997, 4163851, 4171554, 4176212, 4176213, 4180497, 4185426, 4196281, 4201385, 4204821, 4206823, 4209570, 4212783, 4217447, 4218710, 4221348, 4231505, 4231506, 4254255, 4260070, 4267849, 4273428, 4283245, 4289488, 4289489, 4292174, 4322678, 4327893, 4335022, 4335024, 4345018, 4345019, 4345021, 4351242, 4352791, 4374450, 4374451, 4374452, 4374453, 4381024, 4381025, 4381026, 4383637, 4388183, 4388184, 4388185, 4388186, 4389907, 4395792, 4395793, 4399193, 439919

code_info

a) UDI/DI 15021312516760, Product Code/List Number/Item Code 60PFSS30, Lot Numbers: 3868215, 3868216, 3868217, 3868218…

a) UDI/DI 15021312516760, Product Code/List Number/Item Code 60PFSS30, Lot Numbers: 3868215, 3868216, 3868217, 3868218, 3874311, 3880720, 3887755, 3894894, 3904669, 3907971, 3917982, 3926967, 3933476, 3939635, 3942492, 3946278, 3946279, 3946280, 3962580, 3982686, 3988113, 3991183, 4001204, 4011379, 4011380, 4015559, 4029512, 4033728, 4033729, 4040575, 4048009, 4053713, 4060206, 4070853, 4077071, 4077072, 4083908, 4091412, 4096836, 4105256, 4110458, 4113107, 4119118, 4128037, 4130977, 4134021, 4142421, 4145693, 4151047, 4156612, 4159997, 4163851, 4171554, 4176212, 4176213, 4180497, 4185426, 4196281, 4201385, 4204821, 4206823, 4209570, 4212783, 4217447, 4218710, 4221348, 4231505, 4231506, 4254255, 4260070, 4267849, 4273428, 4283245, 4289488, 4289489, 4292174, 4322678, 4327893, 4335022, 4335024, 4345018, 4345019, 4345021, 4351242, 4352791, 4374450, 4374451, 4374452, 4374453, 4381024, 4381025, 4381026, 4383637, 4388183, 4388184, 4388185, 4388186, 4389907, 4395792, 4395793, 4399193, 439919

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-2601-2024%22

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