PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) NEONATAL TRACHEOSTOMY TUBE 2.5mm TTS FLEXTEND V FLANGE , Pro
Summary
The FDA issued a Class I for PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) NEONATAL TRACHEOSTOM by Smiths Medical ASD Inc.. Reason: Smiths Medical has identified that the securement flange of specific lots of the Bivona Neonatal/Pediatric and Adult Tracheostomy products may tear be.
Details
Source
Device Recall
External ID
Z-2608-2024
Action Date
2024-09-04
Status
Ongoing
Category
device
Product Description
PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) NEONATAL TRACHEOSTOMY TUBE 2.5mm TTS FLEXTEND V FLANGE , Product Code/List Number/Item Code 67NFP25; b) NEONATAL TRACHEOSTOMY TUBE 3.0mm TTS FLEXTEND V FLANGE , Product Code/List Number/Item Code 67NFP30; c) NEONATAL TRACHEOSTOMY TUBE 3.5mm TTS FLEXTEND V FLANGE , Product Code/List Number/Item Code 67NFP35; d) NEONATAL TRACHEOSTOMY TUBE 4.0mm TTS FLEXTEND V FLANGE , Product Code/List Number/Item Code 67NFP40
Lot/Code Info: 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
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.
Type: Voluntary: Firm initiated
Recall Initiated: 2024-05-29
Company
Minneapolis, MN
Context & Analysis
This is a Class I recall. Class I recalls are the most serious — there is a reasonable probability that use of or exposure to the product will cause serious health consequences or death.
This was one of 409 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Smiths Medical ASD Inc. has 164 FDA actions in our database, including 162 recalls and 2 clearances.
Frequently Asked Questions
What is a Class I recall?
A Class I recall is the most serious type. The FDA has determined there is a reasonable probability that the product will cause serious adverse health consequences or death. Consumers should stop using the product immediately.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Smiths Medical ASD Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Smiths Medical ASD Inc. have FDA actions?
Smiths Medical ASD Inc. has 164 FDA actions in our database, including 162 recalls and 2 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-2608-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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