FDA recall Z-2717-2024

Covidien · Class II · device

Product

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

Reason for recall

IFU update to address device's battery handling information.

Distribution

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, Kazakh

Key facts

Status
Ongoing
Initiation date
2024-07-09
Report date
2024-08-28
Voluntary/Mandated
Voluntary: Firm initiated
Location
Boulder, CO, United States

Primary source

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