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

FDA device recall Z-2717-2024 · posted 2024-08-22 · Open, Classified

Recall details

Recalling firm

Covidien

Reason for recall

IFU update to address device's battery handling information.

Action taken

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

Status

Open, Classified

Product code

CCW

Quantity affected

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

Date initiated

2024-07-09

Date posted

2024-08-22

Location

Boulder, CO