Rusch Greenlite Single-Use Metal Laryngoscope Blade for Fiber Optic System
- Company
- Teleflex Medical Inc
- Recall Initiated
- January 9, 2020
- Posted
- February 7, 2020
- Terminated
- September 11, 2023
- Recall Number
- Z-1116-2020
- Quantity
- 338,928 (199,018 US and 139,910 OUS) for all products
- Firm Location
- Morrisville, NC
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
Lot / Code Info
Product Code 004551003; Lot Numbers 1811331, 1902331, 1904331
Root Cause
Process control
Action Taken
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.
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