Device product
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)
Z-2183-2025
Product summary
- Event
- Event 97139
- Status
- Ongoing
- Classification
- Class I
- Quantity
- N/A
- Official record key
device-enforcement:Z-2183-2025
Official wording
Reason: Laryngoscope handles may not illuminate as intended.
Code information: Lots: 2007xxxxx to 2012xxxxx (July-2020 to Dec-2020)
Distribution pattern: US Nationwide distribution in the states of WA, SD, TX, VA, PA, OK, GA, MI, WY, NC, OH.
Derived failure modes
-
Unknown
Laryngoscope handles may not illuminate as intended.