FDA recall Z-0726-2021

Smiths Medical ASD Inc. · Class II · device

Product

PORTEX Bivona Cuffless Neonatal/Pediatric FlexTend Tracheostomy Tube, REF 60PFSS45

Reason for recall

A specific model and lot number of Bivona Cuffless FlexTend Tracheostomy Tube may have been incorrectly packaged with a V-neck flange instead of a straight flange.

Distribution

US nationwide distribution.

Key facts

Status: Terminated
Initiation date: 2020-12-15
Report date: 2021-01-06
Termination date: 2022-12-20
Voluntary/Mandated: Voluntary: Firm initiated
Location: Minneapolis, MN, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0726-2021