Recall Z-2637-2024— Covidien

Name: FDA recall Z-2637-2024
Creator: U.S. Food and Drug Administration
Published: 2024-07-09

Class I · Ongoing

Class I FDA medical device recall by Covidien, initiated 2024-07-09. FDA's recall record names no specific 510(k) clearance for this event. Product: McGRATH" MAC EMS Video Laryngoscope, REF: 300-200-000 , Non-Sterile, Rx Only. Reason: Battery management system within Laryngoscope devices may deplete below the deign threshold which may result in thermal event followed by risk of explosion..

Recalling firm: Covidien
Classification: Class I
Status: Ongoing
Initiated: 2024-07-09
Firm location: Boulder, CO, United States

Product description

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

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.