FDA recall Z-2485-2020

Product

Pediatric Adjustable Flange Tracheostomy Tube Cuffless

Reason for recall

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.

Distribution

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

Key facts

Status

Terminated

Initiation date

2020-05-26

Report date

2020-07-08

Termination date

2021-05-05

Voluntary/Mandated

Voluntary: Firm initiated

Location

Minneapolis, MN, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2485-2020