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.
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 15021312000115, Product Code/List Number/Item Code 60SN025, Lot Numbers: 3853489, 3868323, 3955794, 4006293, 4035766, 4066280, 4089302, 4134028, 4173737, 4322691, 4327883, 4353056; b) UDI/DI 15021312000122. Product Code/List Number/Item Code 60SN030, Lot Numbers: 3874310, 3930032, 3946244, 3949032, 3952375, 3959303, 3965337, 3965338, 4006292, 4060224, 4077090, 4092647, 4110469, 4130991, 4159969, 4197627, 4209588, 4254284, 4286821, 4327917, 4335078, 4348783, 4353057, 4383659, 4395805; c) UDI/DI 15021312000139, Product Code/List Number/Item Code 60SN035, Lot Numbers: 3871055, 3897844, 3926955, 3952357, 3952358, 3952359, 3962568, 3991208, 3997824, 4008232, 4015594, 4023794, 4033738, 4035767, 4063193, 4086034, 4092629, 4107577, 4122445, 4134010, 4151017, 4156658, 4168183, 4176207, 4196299, 4206845, 4209589, 4221360, 4223741, 4223742, 4254285, 4260079, 4276484, 4322692, 4335079, 4345044, 4348748, 4348785, 4348786, 4381038, 4382717, 4389930, d) UDI/DI 15021312000184, Product Code/List Number/Item Code 60SN040, Lot Numbers: 3861128, 3868285, 3907976, 3952368, 3952369, 3991209, 4015601, 4026674, 4053715, 4077098, 4091399, 4107593, 4116093, 4125818, 4134020, 4151046, 4176211, 4212793, 4233982, 4254286, 4286822, 4292184, 4348750, 4348787, 4348788, 4348789; e) UDI/DI 15021312000344, Product Code/List Number/Item Code 60SP025, Lot Numbers: 3853490, 3894874, 3952363, 4008233, 4053702, 4091396, 4110470, 4145716, 4156636, 4168173, 4179371, 4197628, 4204827, 4216338, 4223743, 43278
15021312000115, 15021312000122, 15021312000139, 15021312000184, 15021312000344, 15021312000368, 15021312000375, 15021312000382, 15021312000399, 15021312000405, 15021312000436
Official record: FDA (Device enforcement) ↗
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