FDA recall Z-2946-2020

Product

Bivona Mid-Range Aire-Cuf Adult Tracheostomy Tube This tube is intended to provide direct airway access for a tracheotomized patient for up to 29 days. It may be reprocessed up to 10 times for single patient use.

Reason for recall

Label has the incorrect size for the tracheotomy tube.

Distribution

US Distribution to state of: CT

Key facts

Status

Terminated

Initiation date

2020-08-28

Report date

2020-09-16

Termination date

2021-05-13

Voluntary/Mandated

Voluntary: Firm initiated

Location

Minneapolis, MN, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2946-2020