Device product
Rusch Greenlite Single-Use Metal Laryngoscope Blade for Fiber Optic System
Z-1117-2020
Product summary
- Event
- Event 84702
- Status
- Terminated
- Classification
- Class II
- Quantity
- 338,928 (199,018 US and 139,910 OUS) for all products
- Official record key
device-enforcement:Z-1117-2020
Official wording
Reason: The products are being recalled due to reports of breakage broke at the point of a welded joint either prior to use during setup or during use inside the patient's mouth.
Code information: Product Code 004551004; Lot Numbers 1812341, 1903341
Distribution pattern: Distributed nationwide in the US and to Puerto Rico; OUS to more than 20 countries; To the following government VA medical Centers: VAMC - KANSAS CITY MO 4801 E Linwood Blvd Kansas City MO 64128-2218
Derived failure modes
-
Unknown
The products are being recalled due to reports of breakage broke at the point of a welded joint either prior to use during setup or during use inside the patient's mouth.