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

FDA Device Recall #Z-1117-2020 — Class II — January 9, 2020

Recall Summary

Recall Number Z-1117-2020
Classification Class II — Moderate risk
Date Initiated January 9, 2020
Status Terminated
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm TELEFLEX MEDICAL INC
Location Morrisville, NC
Product Type Devices
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

Lot / Code Information

Product Code 004551004; Lot Numbers 1812341, 1903341

Other Recalls from TELEFLEX MEDICAL INC

Recall # Classification Product Date
Z-1126-2022 Class II (1) Gibeck Humid-Vent 2S Flex DC, Product #1773... Apr 11, 2022
Z-1127-2022 Class II (1) Teleflex Flex tube, Product #20011, sterile... Apr 11, 2022
Z-0628-2022 Class I 5 Fr. X 65 cm Arrow-Trerotola PTD Kit, Percutan... Jan 11, 2022
Z-0625-2022 Class I Arrow-Trerotola Over-The-Wire PTD Kit, Percutan... Jan 11, 2022
Z-0623-2022 Class I Arrow-Trerotola Over-The-Wire PTD Kit, Percutan... Jan 11, 2022

Frequently Asked Questions

Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.

Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.

Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.

What Should You Do?

Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.