PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) TTS TRACHEOSTOMY TUBE 7.0MM TIGHT TO SHAFT CUFF, Product Cod

Summary

The FDA issued a Class I for PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) TTS TRACHEOSTOMY TUB by Smiths Medical ASD Inc.. Reason: Smiths Medical has identified that the securement flange of specific lots of the Bivona Neonatal/Pediatric and Adult Tracheostomy products may tear be.

Details

Product Description

PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) TTS TRACHEOSTOMY TUBE 7.0MM TIGHT TO SHAFT CUFF, Product Code/List Number/Item Code 670170; b) TTS TRACHEOSTOMY TUBE 8.0MM TIGHT TO SHAFT CUFF 1/EA, Product Code/List Number/Item Code 670180

Lot/Code Info: a) UDI/DI 15021312006056. Product Code/List Number/Item Code 670170, Lot Numbers: 3774400, 3774401, 3774402, 3774406, 3774411, 3774412, 3774413, 3778527, 3778528, 3778529, 3778530, 3778531, 3778532, 3778533, 3778534, 3778535, 3782488, 3782489, 3782490, 3782491, 3782492, 3790081, 3790082, 3790083, 3790084, 3790085, 3790086, 3790087, 3790088, 3790089, 3790090, 3790091, 3790092, 3790093, 3790094, 3790095, 3790096, 3790097, 3790098, 3790099, 3790100, 3797100, 3797101, 3797102, 3797103, 3797104, 3797105, 3797106, 3797107, 3797108, 3797109, 3797112, 3797113, 3797114, 3797115, 3797116, 3800538, 3800539, 3800540, 3800541, 3800542, 3800543, 3800544, 3800545, 3800546, 3800547, 3800548, 3800549, 3800550, 3800551, 3800552, 3800553, 3801603, 3801604, 3801605, 3801606, 3801607, 3801608, 3801609, 3801610, 3801611, 3801612, 3801613, 3801614, 3801615, 3801616, 3801617, 3801618, 3801619, 3801620, 3801621, 3801622, 3801623, 3801624, 3801625, 3801626, 3801627, 3801628, 3801629, 3801630, 3801631, 3801632, 3801633, 3801634, 3801635, 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4382327, 4382329, 4382330, 4382331, 4382332, 4384899, 4384900, 4384901, 4384902, 4384903, 4384904, 4384905, 4384906, 4390905, 4391727, 4392982, 4393024, 4393380; b) UDI/DI 15021312006070, Product Code/List Number/Item Code 670180, Lot Numbers: 3782494, 3782495, 3782496, 3782497, 3782498, 3782500, 3790009, 3790010, 3790011, 3790012, 3790013, 3790014, 3790015, 3790016, 3790017, 3794163, 3794164, 3794176, 3797110, 3797111, 3797122, 3797123, 3800555, 3800556, 3800557, 3800558, 3800559, 3801403, 3801404, 3801405, 3801406, 3801407, 3801408, 3801409, 3801410, 3801411, 3801412, 3801413, 3801414, 3801415, 3801416, 3801417, 3801418, 3801419, 3801420, 3801421, 3801422, 3801423, 3801424, 3801425, 3801426, 3801427, 3801428, 3801429, 3828128, 3828129, 3828130, 3828131, 3828132, 3828133, 3828134, 3828135, 3828136, 3828137, 3828138, 3828139, 3828140, 3828141, 3828142, 3828143, 3831758, 3831759, 3831760, 3831761, 3831762, 3831763, 3835580, 3835581, 3835582, 3839631, 3839632, 3839633, 3839634, 3845031, 3845032, 3845033, 3845034, 3845035, 3845036, 3845037, 3845038, 3849158, 3849159, 3849160, 3849161, 3849162, 3849163, 3852711, 3852712, 3852713, 3852714, 3852715, 3852716, 3852717, 3852718, 3869823, 3869824, 3869825, 3869826, 3869827, 3869828, 3869829, 3869830, 3869831, 3869832, 3869833, 3869834, 3869835, 3869836, 3869837, 3869838, 3869839, 3869840, 3869841, 3869842, 3869843, 3890265, 3890266, 3890267, 3890268, 3890269, 3890270, 3890271, 3890272, 3890273, 3890274, 3890275, 3890276, 3890277, 3890278, 3890279, 3890280, 3890281, 3890282, 3890283, 3890284, 3890285, 3890286, 3890287, 3890288, 3890289, 3890290, 3890291, 3890292, 3890293, 3890294, 3890295, 3890296, 3890297, 3890298, 3890299, 3890300, 3890301, 3890302, 3890303, 3890304, 3890305, 3890306, 3890307, 3890308, 3891458, 3891459, 3894720, 3894721, 3894722, 3894723, 3894724, 3894725, 3894726, 3894727, 3894728, 3894729, 3894730, 3897755, 3901172, 3901173, 3901174, 3901175, 3901178, 3901181, 3901182, 3901187, 3904524, 3904525, 3904526, 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Quantity Affected: 177340 units

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.

Type: Voluntary: Firm initiated

Recall Initiated: 2024-05-29

Company