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Open, Classified

McGRATH X3 Disposable Laryngoscope Blades-used with the McGRATH MAC Video Laryngoscope to aid the intubation of the trachea Code: X3-002-000 (Individual Unit); X3-003-000 (Carton of 10 Units) - Product Usage: is a tool used to aid the intubation of the trachea. As a rigid laryngoscope it holds and shapes the anatomy allowing a clear view of the larynx and entrance to the trachea.

FDA Recall Z-1408-2020 · Posted 2020-02-10

Recalling FirmMedtronic, PLC
Recall StatusOpen, Classified
Product CodeCCW
Date Initiated2020-01-28
Product Quantity109,897

Reason for Recall

Blades do not fit the McGRATH MAC video laryngoscope handle or were tight fitting on the handles which may result in a change in optical performance as displayed on the video screen

Firm Action

Medtronic issued Medical Device Correction letter via Federal Express and/or certified mail beginning January 28, 2020. The letter states reason for recall, health risk and action to take: dispose of affected product according to their institutions disposal procedures;" Notify all care environments about this notice in which the McGRATH" X3 disposable laryngoscope blades are used;" Promptly forward the information from the customer communication to any recipients to whom they have distributed any of the affected; product; Complete the acknowledgment and receipt form. Questions: Customer Service at (800) 448-3644, Option 2, Option 2.

Root Cause

Under Investigation by firm

Distribution Pattern

Worldwide distribution - US Nationwide and countries Australia, Canada, New Zealand, India, Korea, Japan, Indonesia, Malaysia, Philippines, Singapore, Vietnam, Latin America, France, Switzerland. Italy, Belgium, Germany, Netherlands, Denmark, Poland, Austria, Czech Republic, Croatia, Spain, Finland,Greece, Guadeloupe, Ireland, Hungry, Italy, Jordan, Kazakhstan, Lithuania, Lebanon, Luxembourg, Norway, Poland, Portugal, Reunion, Romania, Russian Federation, Saudia Arabia, Sweden, Serbia, Slovakia, Turkey, Tunisia, United Arab Emirates, United Kingdom.

Official Source

View FDA Recall →

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

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