Class II
Medical Device Recall: Otological Ventilation Tube - Donaldson - Blue Silicone; Product Code: NZ3321;
Adept Medical Ltd · November 24, 2024
Reason for Recall
Lack of 510(k) clearance.
Distribution
US Nationwide distribution. International: Canada, New Zealand, Australia, Yemen, United Kingdom, Spain, Italy, Turkey, El Salvador, Malaysia, United Arab Emirates, Germany, Greece, Syria, Peru, Hong Kong, Turkey, Chile, Ireland.
States Affected
NATIONWIDE
Quantity Affected
2,440 units (1940 US, 500 OUS)
Source: FDA (openFDA Device Enforcement)
Recall number: Z-0969-2025
Status: ongoing
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