FDA-Device2025-08-13Class I
BritePro Solo Single-Use Fiber Optic Handle and Blade Refs: 040-331U (Mac 1), 040-332U (Mac 2), 040-333U (Mac 3), 040-335U (Mac 3.5) 040-334U (Mac 4), 040-341U (Miller 1), 040-342U (Miller 2), 040-343U (Miller 3), 040-344U (Miller 4), 040-361U (Phillips 1), 040-362U (Phillips 2)
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 Single-Use Fiber Optic Handle and Blade Refs: 040-331U (Mac 1), 040-332U (Mac 2), 040-333U (Mac 3), 040-335U (Mac 3.5) 040-334U (Mac 4), 040-341U (Miller 1), 040-342U (Miller 2), 040-343U (Miller 3), 040-344U (Miller 4), 040-361U (Phillips 1), 040-362U (Phillips 2)
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2183-2025Don't want to check this manually?
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