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Terminated

Sun Med GreenLine/D Laryngoscope Blades Compatible with Fiber Optic Green System Handles, Sterile Disposable. Contents 20.

FDA Recall Z-0459-2009 · Posted 2008-12-24

Recalling FirmSun Med, Inc.
Recall StatusTerminated
Product CodeCCW
Date Initiated2007-04-27
Date Terminated2010-07-06
Product Quantity2,682 boxes (20 per box)

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.

Firm 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.

Root Cause

Device Design

Distribution Pattern

Nationwide Distribution

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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