Reported Sep 4, 2024 · Ongoing
PORTEX Bivona Tracheostomy Silicone Tube, labeled as: 2.5MM AIRE-CUF NEONATAL TRACHEOSTOMY TUBE , Product Code/List…
Smiths Medical ASD Inc.
High riskUsing this product could cause serious injury, illness or death — stop using it now.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Smiths Medical ASD Inc. · 6000 Nathan Ln N · Minneapolis, MN · 55442-1690
Is this the product you have?
- PORTEX Bivona Tracheostomy Silicone Tube
- labeled as
2.5MM AIRE-CUF NEONATAL TRACHEOSTOMY TUBEProduct Code/List Number/Item Code 65SN0253.0MM AIRE-CUF NEONATAL TRACHEOSTOMY TUBEProduct Code/List Number/Item Code 65SN0303.5MM AIRE-CUF NEONATAL TRACHEOSTOMY TUBEProduct Code/List Number/Item Code 65SN0354.0MM AIRE-CUF NEONATAL TRACHEOSTOMY TUBEProduct Code/List Number/Item Code 65SN0402.5MM AIRE-CUF PEDIATRIC TRACHEOSTOMY TUBEProduct Code/List Number/Item Code 65SP0253.0MM AIRE-CUF PEDIATRIC TRACHEOSTOMY TUBEProduct Code/List Number/Item Code 65SP0303.5MM AIRE-CUF PEDIATRIC TRACHEOSTOMY TUBEProduct Code/List Number/Item Code 65SP0354.0MM AIRE-CUF PEDIATRIC TRACHEOSTOMY TUBEProduct Code/List Number/Item Code 65SP0404.5MM AIRE-CUF PEDIATRIC TRACHEOSTOMY TUBEProduct Code/List Number/Item Code 65SP0455.0MM AIRE-CUF PEDIATRIC TRACHEOSTOMY TUBEProduct Code/List Number/Item Code 65SP0505.5MM AIRE-CUF PEDIATRIC TRACHEOSTOMY TUBEProduct Code/List Number/Item Code 65SP055
- Lot codes and dates
11 of 11 products
Products covered by this recall # Barcodes Product as published 1 15021312000016UDI/DI 15021312000016, Product Code/List Number/Item Code 65SN025, Lot Numbers: 4060220, 4119090, 4180463, 4201335, 4204802, 4374400, 4393388 2 15021312000030UDI/DI 15021312000030, Product Code/List Number/Item Code 65SN030, Lot Numbers: 3965331, 4119093, 4139005, 4163833, 4171566, 4267838, 4351231, 4399123 3 15021312000061UDI/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 4 15021312000085UDI/DI 15021312000085, Product Code/List Number/Item Code 65SN040, Lot Numbers: 4043945, 4068907, 4075245, 4204803, 4216297, 4218689, 4254207, 4328206 5 1502131200027615021312000276UDI/DI 15021312000276, Product Code/List Number/Item Code 65SP025, Lot Numbers: 4016047, 4016048, 4213398, 4221327,15021312000276, 4344963, 4348391, 4388093, 4389864 6 15021312000283UDI/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 7 15021312000290UDI/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 8 15021312000306UDI/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 9 15021312000313UDI/DI 15021312000313, Product Code/List Number/Item Code 65SP045, Lot Numbers: 3955777, 3997788, 4035685, 4097822, 4113119, 4122433, 4138986, 4173720, 4240121, 4334874, 4348399, 4388095, 4399124 10 15021312000320UDI/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 11 15021312000337UDI/DI 15021312000337, Product Code/List Number/Item Code 65SP055, Lot Numbers: 3897865, 3952418, 3987925, 4005582, 4105263, 4113111, 4159977, 4173722, 4204805, 4328207, 4334875, 4348403, 4353066
This recall covers 28 products
The agency filed one notice per product. You are reading one of them; the other 27 are below.
15 more are in the archive.
Why it was recalled
Stop using this product now
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.
Using this product could cause serious injury, illness or death — stop using it now.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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