Z-1117-2020 Class II Terminated
FDA device recall Z-1117-2020 was initiated by TELEFLEX MEDICAL INC on January 9, 2020 and is designated Class II. Reason for recall: 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. The recall status is terminated (terminated September 11, 2023). Affected quantity: 338,928 (199,018 US and 139,910 OUS) for all products.
Recall Details
- Product Type
- Devices
- Report Date
- February 19, 2020
- Initiation Date
- January 9, 2020
- Termination Date
- September 11, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 338,928 (199,018 US and 139,910 OUS) for all products
Product Description
Rusch Greenlite Single-Use Metal Laryngoscope Blade for Fiber Optic System
Reason for Recall
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.
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
Code Information
Product Code 004551004; Lot Numbers 1812341, 1903341