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Recall Observatory FDA recall evidence

Device product

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.

Z-1408-2020

January 28, 2020

Class II

Product summary

Firm
Medtronic, PLC
Event
Event 84819
Status
Ongoing
Classification
Class II
Quantity
109,897
Official record key
device-enforcement:Z-1408-2020

Official wording

Reason: 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

Code information: UDI: 15060272980082 Lot/Serial #: M1811191 M1811261 M1812071 M1812271 M1901081 M1901161 M1902251 M1903131 M1904031 M1904241 M1906031 M1906121

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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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