Smiths Medical ASD Inc.: PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) NEONATAL TRACHEOSTOMY TUBE 2.5FLEXTEND PLUS , Product Code/List Number/Item Code 60NFP25; b) NEONATAL TRACHEOSTOMY TUB

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 15021312014716, Product Code/List Number/Item Code 60NFP25, Serial Numbers: 3939632, 3942500, 4016061, 4204813, 4334983, 4348458; b) UDI/DI 15021312014723, Product Code/List Number/Item Code 60NFP30, Serial Numbers: 3868231, 3877660, 3884269, 3894895, 3907972, 3917986, 3927831, 3939639, 3949048, 3955816, 3955817, 3982651, 3988077, 4001129, 4018515, 4023787, 4035728, 4043933, 4053733, 4060214, 4066286, 4086006, 4093728, 4100888, 4125803, 4151031, 4156611, 4159945, 4168188, 4179353, 4180468, 4204814, 4206813, 4218703, 4231491, 4233959, 4276460, 4322672, 4334984, 4351234, 4365774, 4369590, 4374425, 4381011, 4388152, 4388153, 4389890, 4399162; c) UDI/DI 15021312014730, Product Code/List Number/Item Code 60NFP35, Serial Numbers: 3840087, 3853439, 3874300, 3880697, 3894865, 3901301, 3917996, 3930057, 3939659, 3949049, 3955818, 3962596, 3982647, 3982648, 3982649, 3982650, 3988078, 3991141, 3991142, 4001198, 4008208, 4008209, 4029505, 4033718, 4070851, 4077108, 4093729, 4122434, 4156641, 4159993, 4173730, 4196271, 4209562, 4217440, 4231492, 4233960, 4240143, 4276461, 4322673, 4334985, 4348459, 4351235, 4374426, 4374427, 4374428, 4383621, 4388154, 4388155, 4389891; d) UDI/DI 15021312014747, Product Code/List Number/Item Code 60NFP40, Serial Numbers: 3840062, 3877647, 3891522, 3904684, 3920949, 3931151, 3959302, 3982645, 3982646, 3982652, 3991143, 3991144, 4001200, 4008210, 4015521, 4107579, 4212772, 4237378, 4322674, 4347201, 4362843, 4369591, 4374429, 4388156, 4389892, 4393

UPC codes

15021312014716, 15021312014723, 15021312014730, 15021312014747

Source

Official record: FDA (Device enforcement) ↗

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