Smiths Medical ASD Inc. recalls PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) TTS TRACHEOSTOMY TUBE 7.0MM TIGHT TO SHAFT CUFF, Product Cod

Recalled September 4, 2024 · FDA recall Z-2588-2024 · 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

Units

177340 units

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) TTS TRACHEOSTOMY TUBE 7.0MM TIGHT TO SHAFT CUFF, Product Code/List Number/Item Code 670170; b) TTS TRACHEOSTOMY TUBE 8.0MM TIGHT TO SHAFT CUFF 1/EA, Product Code/List Number/Item Code 670180

Manufacturer(s)

Smiths Medical ASD Inc.

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