McGRATH" MAC EMS Video Laryngoscope, REF: 300-200-000 , Non-Sterile, Rx Only

FDA device recall Z-2637-2024 · posted 2024-08-21 · Open, Classified

Recall details

Recalling firm

Covidien

Reason for recall

Battery management system within Laryngoscope devices may deplete below the deign threshold which may result in thermal event followed by risk of explosion.

Action taken

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 specified serial numbers have been transferred or distributed. 4. Please complete the enclosed Customer Confirmation Form even if you do not have affected inventory. On 9/11/24, updated removal notices were mailed or emailed to customers expanding the recall to include affected video laryngoscopes shipped prior to 2019 that are now past their 5-year useful life and the batteries should be removed, devices should be removed from service and disposed of. The other actions above are the same.

Root cause

Device Design

Status

Open, Classified

Product code

CCW

Quantity affected

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

Date initiated

2024-07-09

Date posted

2024-08-21

Location

Boulder, CO