Smiths Medical ASD Inc. recalls Pediatric Adjustable Flange Tracheostomy Tube Cuffless

Recalled July 8, 2020 · FDA recall Z-2485-2020 · Smiths Medical ASD

Hazard

One lot of 3.0mm Bivona Cuffless Adjustable Neck Flange Hyperflex Pediatric Tracheostomy Tubes was packaged with a 3.5mm ID adjustable neck flange plate. · FDA Class II

Units

20 devices

Sold at

U.S: NE, TN, TX, and MS. Worldwide: France, Sweden, United Arab Emirates, UK, Netherlands, Czechia, Australia and Denmark.

Description

One lot of 3.0mm Bivona Cuffless Adjustable Neck Flange Hyperflex Pediatric Tracheostomy Tubes was packaged with a 3.5mm ID adjustable neck flange plate.

Product

Pediatric Adjustable Flange Tracheostomy Tube Cuffless

Manufacturer(s)

Smiths Medical ASD Inc.

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