Smiths Medical ASD Inc.: PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) PAED. TRACHEOSTOMY TUBE 2.5MM AIRE-CUF , Product Code/List Number/Item Code 65P025; b) PAED. TRACHEOSTOMY TUBE 3.0MM A

Hazard

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.

Details from the source

Reason for recall: 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. Distribution: Worldwide distribution. Lot/code info: a) UDI/DI 15021312005943, Product Code/List Number/Item Code 65P025, Lot Codes: 3897888, 3981971, 4016049, 4334862, 4374393, 4380064, 4393387, 4400619; b) UDI/DI 15021312005950, Product Code/List Number/Item Code 65P030, Lot Codes: 3880701, 3904666, 3923718, 3926981, 3930042, 4171565, 4196257, 4221324, 4331542, 4334863, 4348379, 4374394, 4388089; c) UDI/DI 15021312005967, Product Code/List Number/Item Code 65P035, Lot Codes: 3864229, 3908001, 3920948, 3923722, 3931150, 3942487, 3955807, 4035680, 4056227, 4086031, 4119112, 4142431, 4147993, 4237343, 4331543, 4334864, 4348380, 4348382, 4369540, 4380065, 4395735; d) UDI/DI 15021312005974, Product Code/List Number/Item Code 65P040, Lot Codes: 3853369, 3868319, 3887746, 3904668, 3942471, 3950391, 3952347, 3965907, 4116095, 4145712, 4153617, 4213393, 4237344, 4289465, 4334865, 4348383, 4348384, 4348385, 4374395, 4383591; e) UDI/DI 15021312005981, Product Code/List Number/Item Code 65P045, Lot Codes: 3868312, 3871060, 3904681, 3904682, 3933472, 4080790, 4089308, 4107571, 4131006, 4145718, 4153595, 4161990, 4204801, 4216296, 4292150, 4334866, 4344346, 4348387, 4374396, 4380066, 4400620; f) UDI/DI 15021312005998, Product Code/List Number/Item Code 65P050, Lot Codes: 3868226, 3871030, 3871031, 3911435, 3930040, 3942493, 3955805, 4015525, 4092637, 4110429, 4139011, 4163824, 4179335, 4213394, 4221325, 4289466, 4328204, 4334867, 4351222, 4369532, 4369533, 4380991, 4388090, g) UDI/DI 15021312006001, Product Code/List Number/Item Code 65P05

UPC codes

15021312005943, 15021312005950, 15021312005967, 15021312005974, 15021312005981, 15021312005998, 15021312006001

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.