Device product
BritePro Solo Single-Use Fiber Optic Mini Handle and Blade Ref: 040-02-0110U (Mac 1), 040-02-0120U (Mac 2), 040-02-0130U (Mac 3), 040-02-0131U (Mac 3 Strong Curve) 040-02-0140U (Mac 4), 040-02-0400U (Miller 00), 040-02-0410U (Miller 1), 040-02-0420U (Miller 2), 040-02-0430U (Miller 3),
Z-2182-2025
Product summary
- Event
- Event 97139
- Status
- Ongoing
- Classification
- Class I
- Quantity
- N/A
- Official record key
device-enforcement:Z-2182-2025
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.