Laryngoscope Recall: Part of Device Blades May Break Off
Published: December 22nd, 2008 • No Comments
The FDA and Sun Med have posted a notice to ENT, anesthesia and critical care healthcare professionals about a laryngoscope recall issued for Greenline/D MacIntosh No. 3 Laryngoscope Blades, which contain a piece of acrylic light tube that may break off during medical procedures to view the vocal cords and other structures when opening a patient’s airway.
The disposable, sterile, stainless steel laryngoscope blades were manufactured between July 2006 and March 2007, and could have been used since January 16, 2007. The recall applies to lot codes Gj and Ha.
A laryngoscope is a medical instrument used to obtain a view of the vocal cords and the space between the cords. The recalled part contains a piece of acrylic light tupe that runs along the laryngoscope blade that could break off during the procedure.
The action has been classified by the FDA as a Class 1 Recall, which is used for dangerous or defective products that predictably could cause serious injury or death.
The manufacturer, Sun Med of Largo, Florida, has notified their distributors of this recall, requesting that the products be returned. Healthcare providers have been encouraged to report any problems with the use of this laryngoscope by contacting the FDA MetWatch Adverse Reporting program.
