Class 2 Device Recall Rusch Greenlite SingleUse Metal Laryngoscope

• Date Initiated by Firm: January 09, 2020
• Date Posted: February 07, 2020
• Recall Status: Terminated on September 11, 2023
• Recall Number: Z-1116-2020
• Recall Event ID: 84702
• Product Classification: Laryngoscope, rigid - Product Code CCW
• Product: Rusch Greenlite Single-Use Metal Laryngoscope Blade for Fiber Optic System
• Code Information: Product Code 004551003; Lot Numbers 1811331, 1902331, 1904331
• FEI Number: 3005747797
• Recalling Firm/ Manufacturer: TELEFLEX MEDICAL INC; 3015 Carrington Mill Blvd; Morrisville NC 27560-5437
• For Additional Information Contact: 855-419-8507
• Manufacturer 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.
• FDA Determined Cause: Process control
• 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.
• Quantity in Commerce: 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
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 �7.55.