Recall Z-2637-2024 ยท CCW Laryngoscope, Rigid
Covidien
McGRATH" MAC EMS Video Laryngoscope, REF: 300-200-000 , Non-Sterile, Rx Only
| Date | Aug 21, 2024 (initiated Jul 9, 2024) |
| Status | Open, Classified |
| Reason | Battery management system within Laryngoscope devices may deplete below the deign threshold which may result in thermal event followed by risk of explosion. |
| Root cause | Device Design |
| Action | On July 17, 2024, Medtronic issued a "Urgent Medical Device Removal and Correction" notification to affected consignees via Mail and/or E-Mail. Medtronic ask consignees to take the following actions: Immediately discontinue use of the devices being removed (300-000-000 and 300-200-000). 1. Uninstall and dispose of the battery assembly from the devices being removed. 2. Return the removed device (300-000-000 and 300-200-000) to Medtronic. 3. 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 specifie |
| Quantity | 10,449 units |
| 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, Virgin Islan |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.