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Medical Devices Sector
قطاع الأجهزة الطبية
National Center for Medical Devices Reporting
المركز الوطني لبلاغات الأجهزة والمنتجات الطبية
NCMDR Recall
Reference Number: mdprc 016 06 13 000
Date submitted: 6/4/2013
Manufacturer:Verathon Inc
Device Type:GlideScope Reusable AVL, GVL, and Ranger Laryngoscope Blades
Description:Laryngoscope Blades
Medical Device Identifier:Section 1– discontinue use for the following GlideScope Video Laryngoscope Blades; Product name: AVL2 Part Nos.:0574-0118 Serial Nos.: AC111500 through AC121604 Product name: AVL3 Part Nos.: 0574-0115 Serial Nos.: AD111500 through AD121688 Product name: AVL4 Part Nos.: 0574-0116 Serial Nos.: AE111500 through AE121778 Product name: AVL5 Part Nos.: 0574-0117 Serial Nos.: AF111500 through AF121666 Product name: GVL3 Part Nos.: 0574-0007 Serial Nos.: MD112388 through MD121908 Product name: GVL4 Part Nos.: 0574-0001 Serial Nos.: LG112759 through LG122582 Product name: GVL5 Part Nos.: 0574-0030 Serial Nos.: XL111799 through XL121759 Section 2– monitor for wear or damage for the following GlideScope Video Laryngoscope Blades: Product Name: AVL2 Part Nos.:0574-0118 Serial Nos.: All serial numbers
Reason of Field Safety Corrective Action:May Break during Use
Remedy Action:Discontinue use of affected blades. Verathon states that it will replace each affected blade with new product at no cost to your facility, or it will replace reusable blades with a single-use laryngoscope configuration. A Verathon representative will contact your facility to arrange for product replacement..
Athorized Representative/Importer/Distributor:Techno-Orbits Establishment , Riyadh , (011) 2293 142
Report Source:NCMDR
Source Ref. Number:26AD67C09E298
SFDA Comments:SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Attachments: Verathon.pdf