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FDA > CDRH > Medical Device Recalls > Sun Med Greenline/D MacIntosh No. 3 Laryngoscope Blades

Class 1 Recall: Sun Med Greenline/D MacIntosh No. 3 Laryngoscope Blades

Date Recall Initiated	April 27, 2007
Product:	Greenline/D MacIntosh No. 3 Laryngoscope Blades, Sterile and Disposable, Contents 20/box. This recall only involves lot codes Gj and Ha. This device was manufactured from July, 2006 through March, 2007 and distributed from January 16, 2007 through April 13, 2007.
Use:	The blades are part of a medical device (laryngoscope) used to view the vocal cords and other structures when opening a patient’s airway.
Recalling Firm:	Sun Med 12393 Belcher Road, Suite 450 Largo, Florida 33773-3097
Reason for Recall:	A piece of the acrylic light tube that runs along the laryngoscope blade may break off during the procedure.
Public Contact:	The company may be contacted at 1-727-530-7099.
FDA District:	Florida
FDA Comment:	The company sent a notice to their distributors requesting that the product be returned. Healthcare professionals and consumers may report any problems with the use of this product to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by FAX. Online: www.fda.gov/MedWatch/report.htm Regular Mail: use postage-paid FDA form 3500 available at: www.fda.gov/MedWatch/getforms.htm Mail to MedWatch 5600 Fishers Lane, Rockville, MD 20852-9787 FAX: 1-800-FDA-0178

Updated December 19, 2008

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