Device product
Britepro Solo Stubby Single-Use Fiber Optic Laryngoscope Handle REF:040-03-0000U
Z-2185-2025
Product summary
- Event
- Event 97139
- Status
- Ongoing
- Classification
- Class I
- Quantity
- N/A
- Official record key
device-enforcement:Z-2185-2025
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.