Smiths Medical ASD Inc.: PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) NEONATAL TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 60N025

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. Quantity: 3138 units Lot/code info: a) UDI/DI 15021312005684, Product Code/List Number/Item Code 60N025, Lot Numbers: 3853476, 3868313, 3911441, 3952404, 3965318, 3991202, 4006287, 4006294, 4097838, 4125826, 4148013, 4185431, 4206833, 4221354, 4238779, 4331627, 4345039, 4348774, 4383653, 4400691

UPC codes

15021312005684

Source

Official record: FDA (Device enforcement) ↗

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