FDA-Device2025-08-13Class I

BritePro Solo Mini Single-Use Fiber Optic Laryngoscope Handle REF:040-309U

Flexicare Medical (Dongguan) Ltd.
Hazard

Laryngoscope handles may not illuminate as intended.

Sold states
US Nationwide distribution in the states of WA, SD, TX, VA, PA, OK, GA, MI, WY, NC, OH.
Affected count
N/A
Manufactured in
Hengli Town, No. B-15 Xicheng; Henglizhen, Dongguan, N/A, China
Products
BritePro Solo Mini Single-Use Fiber Optic Laryngoscope Handle REF:040-309U

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2186-2025

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