FDA recall Z-1116-2020

Product

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

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

Key facts

Status

Terminated

Initiation date

2020-01-09

Report date

2020-02-19

Termination date

2023-09-11

Voluntary/Mandated

Voluntary: Firm initiated

Location

Morrisville, NC, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1116-2020