Smiths Medical ASD Inc. recalls PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) 4.0MM FLEXTEND PEDIATRIC PLUS STRAIGHT TRACH TUBE , Product

Recalled September 4, 2024 · FDA recall Z-2598-2024 · Smiths Medical ASD

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. · FDA Class I

Sold at

Worldwide distribution.

Description

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.

Product

PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) 4.0MM FLEXTEND PEDIATRIC PLUS STRAIGHT TRACH TUBE , Product Code/List Number/Item Code 60PFPS40; b) 4.5MM FLEXTEND PEDIATRIC PLUS STRAIGHT TRACH TUBE , Product Code/List Number/Item Code 60PFPS45; c) 5.0MM FLEXTEND PEDIATRIC PLUS STRAIGHT TRACH TUBE , Product Code/List Number/Item Code 60PFPS50; d) 5.5MM FLEXTEND PEDIATRIC PLUS STRIAGHT TRACH TUBE , Product Code/List Number/Item Code 60PFPS55; e) 6.0MM FLEXTEND PEDIATRIC PLUS STRAIGHT TRACH TUBE , Product Code/List Number/Item Code 60PFPS60

Manufacturer(s)

Smiths Medical ASD Inc.

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →