Z-2603-2024 Class I Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- September 4, 2024
- Initiation Date
- May 29, 2024
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
Product 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
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 Pattern
Worldwide distribution.
Code Information
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