PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) NEONATAL TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 65N025; b) NEONATAL TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 65N030; c) NEONATAL TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 65N035; d) NEONATAL TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 65N040
Class I - DangerousWhat Should You Do?
- Check if you have this product: a) UDI/DI 15021312005905, Product Code/List Number/Item Code 65N025, Lot Numbers: 3949029, 4138994, 4171564, 4334857, 4383590; b) UDI/DI 15021312005912, Product Code/List Number/Item Code 65N030, Lot Numbers: 3917999, 3965333, 4142429, 4161978, 4185397, 4197598, 4334858, 4348373; c) UDI/DI 15021312005929, Product Code/List Number/Item Code 65N035, Lot Numbers: 3871033, 3930033, 3942447, 4119099, 4139020, 4159985, 4168187, 4204800, 4213392, 4334859, 4351228, 4374392, 4389861; UDI/DI 15021312005936, Product Code/List Number/Item Code 65N040, Lot Numbers: 3871068, 3952405, 4119119, 4161958, 4221322, 4267836, 4334861, 4348376
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- Smiths Medical ASD Inc.
- 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.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- ongoing
Product Information
Full Description:
PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) NEONATAL TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 65N025; b) NEONATAL TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 65N030; c) NEONATAL TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 65N035; d) NEONATAL TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 65N040
Product Codes/Lot Numbers:
a) UDI/DI 15021312005905, Product Code/List Number/Item Code 65N025, Lot Numbers: 3949029, 4138994, 4171564, 4334857, 4383590; b) UDI/DI 15021312005912, Product Code/List Number/Item Code 65N030, Lot Numbers: 3917999, 3965333, 4142429, 4161978, 4185397, 4197598, 4334858, 4348373; c) UDI/DI 15021312005929, Product Code/List Number/Item Code 65N035, Lot Numbers: 3871033, 3930033, 3942447, 4119099, 4139020, 4159985, 4168187, 4204800, 4213392, 4334859, 4351228, 4374392, 4389861; UDI/DI 15021312005936, Product Code/List Number/Item Code 65N040, Lot Numbers: 3871068, 3952405, 4119119, 4161958, 4221322, 4267836, 4334861, 4348376
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-2603-2024
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