Smiths Medical ASD Inc.: PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) NEONATAL TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 65N025; b) NEONATAL TRACHEOSTOMY TUBE , Product Code/L

Hazard

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.

Details from the source

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. Lot/code info: 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

UPC codes

15021312005905, 15021312005912, 15021312005929, 15021312005936

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.