PORTEX Bivona Tracheostomy Silicone Tube recall
PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) NEONATAL TRACHEOSTOMY TUBE 2.5mm TTS FLEXTEND V FLANGE , Product Code/List Number/Item Code…
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 10351688518736, Product Code/List Number/Item Code 67NFP25, Serial Numbers: 3936586, 4033699, 4091401, 4334881; b) UDI/DI 10351688518743, Product Code/List Number/Item Code 67NFP30, Serial Numbers: 3853379, 3864236, 3874314, 3884252, 3901302, 3930043, 3955792, 3962588, 3997790, 4011356, 4033700, 4063161, 4097823, 4116100, 4145705, 4163839, 4331551, 4334882, 4374402, 4380994; c) UDI/DI 10351688518750, Product Code/List Number/Item Code 67NFP35, Serial Numbers: 3853380, 3874302, 3891535, 3923730, 3939680, 3952399, 3959334, 4001123, 4021415, 4086018, 4110430, 4130984, 4151052, 4176229, 4218691, 4237346, 4331592, 4333982, 4357246, 4383594, 4388098, 4395737; d) UDI/DI 10351688518767Product Code/List Number/Item Code 67NFP40, Serial Numbers: 3853381, 3861138, 3894884, 3923727, 3952393, 3987930, 4033701, 4083924, 4122439, 4156634, 4237348, 4334883, 4388099
- Product
- PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) NEONATAL TRACHEOSTOMY TUBE 2.5mm TTS FLEXTEND V FLANGE , Product Code/List Number/Item Code…
- Recalling firm
- Smiths Medical ASD Inc.
- Distribution
- Worldwide distribution.
- Recall date
- September 4, 2024
- Classification
- Class I
- Status
- Ongoing
- Agency
- FDA (device)