FDA recall Z-3238-2017

Bomimed · Class II · device

Product

BOMImed Disposable Fiber Optic Medium Laryngoscope Handle. Each handle is packaged in an individual peel pouch, 20 handles per box. The rigid laryngoscope handle is a device used along with a blade to examine and visualize a patient's airway and aid placement of a tracheal tube.

Reason for recall

Potential for intermittent lighting (flickering) during use.

Distribution

IL. PA. and WA CANADA

Key facts

Status
Terminated
Initiation date
2017-07-13
Report date
2017-10-11
Termination date
2021-04-01
Voluntary/Mandated
Voluntary: Firm initiated
Location
Winnipeg, N/A, Canada

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3238-2017