Recall Z-0168-2024— Covidien
Class II · Ongoing
Class II FDA medical device recall by Covidien, initiated 2023-08-10. FDA's recall record names no specific 510(k) clearance for this event. Product: McGrath Mac 2, Disposable Laryngoscope Blade, REF: 350-017-000, Sterile EO, Rx Only. Reason: Laryngoscope blades may contain an ineffective application of anti-fog agent which may result in condensation accumulating causing the screen to be blurred or obscured..
- Recalling firm
- Covidien
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2023-08-10
- Firm location
- Boulder, CO, United States
Product description
McGrath Mac 2, Disposable Laryngoscope Blade, REF: 350-017-000, Sterile EO, Rx Only
Reason for recall
Laryngoscope blades may contain an ineffective application of anti-fog agent which may result in condensation accumulating causing the screen to be blurred or obscured.
Data sourced from openFDA. This site is unofficial and independent of the FDA.