PlainRecalls
FDA Devices Moderate Class II Ongoing

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.

Reported: March 11, 2020 Initiated: January 28, 2020 #Z-1408-2020

Product Description

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.

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

Details

Recalling Firm
Medtronic, PLC
Units Affected
109,897
Distribution
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.
Location
North Haven, CT

Frequently Asked Questions

What product was recalled? ▼
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.. Recalled by Medtronic, PLC. Units affected: 109,897.
Why was this product recalled? ▼
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
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on March 11, 2020. Severity: Moderate. Recall number: Z-1408-2020.

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