PlainRecalls
FDA Devices Moderate Class II Terminated

Rusch Greenlite Single-Use Metal Laryngoscope Blade for Fiber Optic System

Reported: February 19, 2020 Initiated: January 9, 2020 #Z-1117-2020

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.

Details

Recalling Firm
TELEFLEX MEDICAL INC
Units Affected
338,928 (199,018 US and 139,910 OUS) for all products
Distribution
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
Location
Morrisville, NC

Frequently Asked Questions

What product was recalled?
Rusch Greenlite Single-Use Metal Laryngoscope Blade for Fiber Optic System. Recalled by TELEFLEX MEDICAL INC. Units affected: 338,928 (199,018 US and 139,910 OUS) for all products.
Why was this product recalled?
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.
Which agency issued this recall?
This recall was issued by the FDA Devices on February 19, 2020. Severity: Moderate. Recall number: Z-1117-2020.