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Recall Observatory FDA recall evidence

Device product

McGrath Mac 2, Disposable Laryngoscope Blade, REF: 350-084-000, Sterile EO, Rx Only

Z-0169-2024

August 10, 2023

Class II

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

    reason.no_named_rule · v1.0.0

    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.