FDA-Device2024-08-28Class II

Covideien McGRATH MAC Video Laryngoscope, REF: 301-000-000, Non-Sterile, RxOnly

Covidien
Hazard

IFU update to address device's battery handling information.

Sold states
Worldwide - US Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY, Puerto Rico, US Virgin Islands and the countries of Albania, Algeria, Andorra, Angola, Argentina, Australia, Austria, Azerbaijan, Bahamas, Bahrain, Bangladesh, Barbados, Belgium, Bermuda, Bhutan, Bosnia And Herzegovina, Botswana, Brazil, Bulgaria, Cambodia, Cameroon, Canada, Canary Islands, Cayman Islands, Chile, China, Colombia, Costa Rica, Croatia, Cyprus, Czech Republic, Denmark, Dominican Rep., Dutch Antilles, Egypt, El Salvador, Estonia, Faroe Islands, Fiji, Finland, France, French, Guiana French, Polynesia, Germany, Ghana, Greece, Guadeloupe, Guatemala, Guyana, Honduras, Hong Kong, Hungary, Iceland, India, Indonesia, Iran, Islamic, Republic Of Iraq, Ireland, Israel, Italy, Jamaica, Japan, Jordan, Kazakhstan, Kenya, Korea, Republic Of Kosovo, Kuwait, Latvia, Lebanon, Libya, Lithuania, Luxembourg, Macao, Malaysia, Maldives, Malta, Martinique, Mauritius, Mexico, Moldova, Republic Of Mongolia, Morocco, Nepal, Netherlands, New Caledonia, New Zealand, Nicaragua, Nigeria, North Macedonia, Norway, Oman, Pakistan, Panama, Peru, Philippines, Poland, Portugal, Puerto Rico, Qatar, Reunion Romania, Russian Federation, Rwanda, Saint Martin, Saint Pierre And Miquelon, Saudi Arabia, Senegal, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Togo, Trinidad And Tobago, Tunisia, Turkey, Turkmenistan, Uganda, Ukraine, United Arab Emirates, United Kingdom, United States Uruguay, Viet Nam, Virgin Islands, U.S., Wallis And Futuna.
Affected count
68,093 devices
Manufactured in
6135 Gunbarrel Ave, Boulder, CO, United States
Products
Covideien McGRATH MAC Video Laryngoscope, REF: 301-000-000, Non-Sterile, RxOnly

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2717-2024

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