PORTEX Bivona Tracheostomy Silicone Tube recall
PORTEX Bivona Tracheostomy Silicone Tube, labeled as: 2.5MM AIRE-CUF NEONATAL TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 65SN025; 3.0MM…
Why was PORTEX Bivona Tracheostomy Silicone Tube recalled?
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 should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
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, 4113108, 4128027, 4138996, 4153578, 4163825, 4168174, 4185399, 4221330, 4237345, 4334873, 4348396, 4348397, 4358513, 4369534; i) UDI/DI 15021312000313, Product Code/List Number/Item Code 65SP045, Lot Numbers: 3955777, 3997788, 4035685, 4097822, 4113119, 4122433, 4138986, 4173720, 4240121, 4334874, 4348399, 4388095, 4399124; j) UDI/DI 15021312000320, Product Code/List Number/Item Code 65SP050, Lot Numbers: 3868214, 3936579, 3952367, 3987924, 3997789, 4029490, 4034958, 4085999, 4095921, 4107590, 4116090, 4122453, 4134016, 4139012, 4159941, 4171570, 4180460, 4197603, 4267839, 4351232, 4352754, 4383592, 4388096, 4389866, 4399125; k) UDI/DI 15021312000337, Product Code/List Number/Item Code 65SP055, Lot Numbers: 3897865, 3952418, 3987925, 4005582, 4105263, 4113111, 4159977, 4173722, 4204805, 4328207, 4334875, 4348403, 4353066
- Product
- PORTEX Bivona Tracheostomy Silicone Tube, labeled as: 2.5MM AIRE-CUF NEONATAL TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 65SN025; 3.0MM…
- Recalling firm
- Smiths Medical ASD Inc.
- Distribution
- Worldwide distribution.
- Recall date
- September 4, 2024
- Classification
- Class I
- Status
- Ongoing
- Agency
- FDA (device)