FDAFDA · Food and drugs·Recall number Z-2592-2024
PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) NEONATAL TRACHEOSTOMY TUBE 2.5FLEXTEND PLUS , Product Code/List Number/Item Code 60NFP25; b) NEONATAL TRACHEOSTOMY TUBE 3.0FLEXTEND PLUS , Product Code/List Number/Item Code 60NFP30; c) NEONATAL TRACHEOSTOMY TUBE 3.5FLEXTEND PLUS , Product Code/List Number/Item Code 60NFP35; d) NEONATAL TRACHEOSTOMY TUBE 4.0FLEXTEND PLUS , Product Code/List Number/Item Code 60NFP40
Published September 4, 2024 · Recall initiated: May 29, 2024
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the 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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Smiths Medical ASD Inc.
- Distributor
- Worldwide distribution.
- Lot
- 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, 4393406, 4399164
- Risk classification
- Class I
- Area (FDA)
- device
- Country
- United States
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