Open, Classified

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

FDA Recall Z-2717-2024 · Posted 2024-08-22

Recalling FirmCovidien

Recall StatusOpen, Classified

Product CodeCCW

Date Initiated2024-07-09

Product Quantity68,093 devices

Reason for Recall

IFU update to address device's battery handling information.

Firm Action

On July 17, 2024 Medtronic issued a "Urgent Medical Device Correction" Notice to affected consignees via US Mail and/or E-Mail. Medtronic ask consignee to take the following actions " 1. Follow Important Battery Handling Information stated in the IFU and provided in this notice and maintain a copy of the addendum with the IFU for McGRATH" MAC Video Laryngoscopes. 2. Pass this notice on to all who need to be aware within your organization or to any organization where the potentially affected product with the specified serial numbers have been transferred or distributed. 3. Please complete the enclosed Customer Confirmation Form even if you do not have affected inventory.

Root Cause

Under Investigation by firm

Distribution Pattern

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.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.