Rusch Greenlite Single-Use Metal Laryngoscope Blade for Fiber Optic System
FDA Recall Z-1116-2020 · Posted 2020-02-07
Recalling FirmTELEFLEX MEDICAL INC
Recall StatusTerminated
Product CodeCCW
Date Initiated2020-01-09
Date Terminated2023-09-11
Product Quantity338,928 (199,018 US and 139,910 OUS) for all products
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.
Firm Action
Letters sent to customers/users to immediately discontinue use and quarantine any products with the affected product code and lot numbers and return them to the manufacturer.
Root Cause
Process control
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
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.