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U.S. Department of Health and Human Services

Class 1 Device Recall GreenLine/D Laryngoscope Blades

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 Class 1 Recall
GreenLine/D Laryngoscope Blades
see related information
Date Posted December 24, 2008
Recall Status1 Terminated on July 06, 2010
Recall Number Z-0459-2009
Recall Event ID 50092
Product Classification Laryngoscope, Rigid - Product Code CCW
Product Sun Med GreenLine/D Laryngoscope Blades Compatible with Fiber Optic Green System Handles, Sterile Disposable. Contents 20.
Code Information Lots: Gj, Ha
Recalling Firm/
Manufacturer
Sun Med, Inc.
12393 Belcher Road, Suite 450
Largo, Florida 33773-3097
For Additional Information Contact Katherine Meadows
727-530-7099
Manufacturer Reason
for Recall
A breakage problem of the acrylic bundles at both distal and proximal ends of the light tube for the MD Laryngoscope Blade GreenLine D Mac 3 has been detected. If breakage occurs during use, there is the potential for leaving approximately a one inch piece of acrylic tube in the patient's mouth.
FDA Determined
Cause 2
DESIGN: Device Design
Action SunMed sent initial recall letter on April 27, 2007 to all distributors requesting that kits containing the MacIntosh size 3, consisting of lots number Gj and Ha be returned to facility. Replacement information was included in letter. On December 12, 2008, the firm issued a Device Recall Press Release with additional information on the potential for the tube to break during use leaving an approximate 1 inch piece of the acrylic tube in the patients mouth and subsequently requiring medical or surgical intervention to prevent serous injury to the patient. SunMed has notified its distributors and customers by certified mail and has arranged for return and replacement of all recalled products. Consumers with question may contact their distributor of the GreenLine/D or SunMed at 1-800-433-2797.
Quantity in Commerce 2,682 boxes (20 per box)
Distribution Nationwide Distribution
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
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