Recall Z-2717-2024 ยท CCW Laryngoscope, Rigid
Covidien
Covideien McGRATH MAC Video Laryngoscope, REF: 301-000-000, Non-Sterile, RxOnly
| Date | Aug 22, 2024 (initiated Jul 9, 2024) |
| Status | Open, Classified |
| Reason | IFU update to address device's battery handling information. |
| Root cause | Under Investigation by 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 |
| Quantity | 68,093 devices |
| 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 I |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.