Smiths Medical ASD Inc.: PORTEX Bivona Tracheostomy Silicone Tube, labeled as: 2.5MM AIRE-CUF NEONATAL TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 65SN025; 3.0MM AIRE-CUF NEONATAL TRACHEOST

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 15021312000016, Product Code/List Number/Item Code 65SN025, Lot Numbers: 4060220, 4119090, 4180463, 4201335, 4204802, 4374400, 4393388; b) UDI/DI 15021312000030, Product Code/List Number/Item Code 65SN030, Lot Numbers: 3965331, 4119093, 4139005, 4163833, 4171566, 4267838, 4351231, 4399123; c) UDI/DI 15021312000061, Product Code/List Number/Item Code 65SN035, Lot Numbers: 3942499, 4033697, 4048018, 4060226, 4107576, 4119094, 4134009, 4156653, 4168191, 4171567, 4197599, 4213396, 4221326, 4334871, 4348390; d) UDI/DI 15021312000085, Product Code/List Number/Item Code 65SN040, Lot Numbers: 4043945, 4068907, 4075245, 4204803, 4216297, 4218689, 4254207, 4328206; e) UDI/DI 15021312000276, Product Code/List Number/Item Code 65SP025, Lot Numbers: 4016047, 4016048, 4213398, 4221327,15021312000276, 4344963, 4348391, 4388093, 4389864; f) UDI/DI 15021312000283, Product Code/List Number/Item Code 65SP030, Lot Numbers: 4035682, 4077097, 4086010, 4116097, 4138989, 4171568, 4173719, 4180488, 4185398, 4197601, 4221329, 4254212, 4331544, 4334872, 4348392; g) UDI/DI 15021312000290, Product Code/List Number/Item Code 65SP035, Lot Numbers: 3868192, 3952355, 4011353, 4033698, 4035683, 4060200, 4075234, 4116087, 4128012, 4139008, 4142433, 4159990, 4171569, 4180459, 4201336, 4204804, 4218690, 4292151, 4344966, 4348395, 4362879, 4380067, 4388094, 4389865; h) UDI/DI 15021312000306, Product Code/List Number/Item Code 65SP040, Lot Numbers: 3897869, 3917985, 4011354, 4035684, 4056234, 4097821, 41

UPC codes

15021312000016, 15021312000030, 15021312000061, 15021312000085, 15021312000276, 15021312000283, 15021312000290, 15021312000306, 15021312000313, 15021312000320, 15021312000337

Source

Official record: FDA (Device enforcement) ↗

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