Device product
McGrath Mac 2, Disposable Laryngoscope Blade, REF: 350-084-000, Sterile EO, Rx Only
Z-0169-2024
Product summary
- Firm
- Covidien
- Event
- Event 92895
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 42,367
- Official record key
device-enforcement:Z-0169-2024
Official wording
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.
Code information: UDI: 10884521824386/ Lot # 22102001
Distribution pattern: US: AK AL AR AZ CA CO CT DE FL GA IA IL IN KS LA MA MD MI MO MT NC ND NH NJ NM NY OH OK OR PA SD TN TX UT VA WA WI WY OUS: Australia Austria Azerbaijan Bahamas Belgium Croatia Czech Republic Denmark Finland France French Guiana Germany Guadeloupe Hong Kong Hungary Ireland Israel Italy Kazakhstan Korea, Republic Of Malta Mayotte Netherlands New Zealand Norway Pakistan Poland Portugal Reunion Romania Spain Sweden Switzerland Turkmenistan United Arab Emirates
Derived failure modes
-
Unknown
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.