FDA-Device2014-12-10Class II
McGrath MAC2 Video Laryngoscope Blades Product supplied in box of 50 items, each individually peel-pouched and EtO sterilized. Product Usage: Single Use, sterile video laryngoscope blade for use with McGRATH MAC Video Laryngoscopes
Aircraft Medical Limited
Hazard
The blade retaining clip may be difficult to engage and thereby increase the possibility of a blade becoming disconnected during intubation, specifically when the device is being retracted from the patients mouth.
Sold states
Worldwide Distribution - US Nationwide in the state of GA and the countries of Austria, China, Denmark, Finland, France, Hong Kong, Israel, Italy, Netherlands, Poland, Saudi Arabia, Singapore, South Korea, Taiwan, and Turkey.
Affected count
40,900 blades (US); 16,000 blades (Foreign)
Manufactured in
9-10 SAINT ANDREW SQUARE, N/A, EDINBURGH, N/A, United Kingdom
Products
McGrath MAC2 Video Laryngoscope Blades Product supplied in box of 50 items, each individually peel-pouched and EtO sterilized. Product Usage: Single Use, sterile video laryngoscope blade for use with McGRATH MAC Video Laryngoscopes
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0494-2015Don't want to check this manually?
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