Home / Recalls / Medtronic, PLC / Z-1408-2020

Z-1408-2020 Class II Ongoing

Recalled by Medtronic, PLC — North Haven, CT

FDA device recall Z-1408-2020 was initiated by Medtronic, PLC on January 28, 2020 and is designated Class II. 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 The recall status is ongoing. Affected quantity: 109,897.

Recall Details

Product Type
Devices
Report Date
March 11, 2020
Initiation Date
January 28, 2020
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
109,897

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

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.

Code Information

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

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FDA data resources