Date Initiated by Firm |
January 09, 2020 |
Date Posted |
February 07, 2020 |
Recall Status1 |
Terminated 3 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 |
Recalling Firm/ Manufacturer |
TELEFLEX MEDICAL INC 3015 Carrington Mill Blvd Morrisville NC 27560-5437
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For Additional Information Contact |
855-419-8507
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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 2 |
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
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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.
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