Otological Ventilation Tube - Donaldson - Blue Silicone; Product Code: NZ3321;
Reported: January 29, 2025 Initiated: November 24, 2024 #Z-0969-2025
Product Description
Otological Ventilation Tube - Donaldson - Blue Silicone; Product Code: NZ3321;
Reason for Recall
Lack of 510(k) clearance.
Details
- Recalling Firm
- Adept Medical Ltd
- Units Affected
- 2,440 units (1940 US, 500 OUS)
- 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.
- Location
- Auckland
Frequently Asked Questions
What product was recalled? ▼
Otological Ventilation Tube - Donaldson - Blue Silicone; Product Code: NZ3321;. Recalled by Adept Medical Ltd. Units affected: 2,440 units (1940 US, 500 OUS).
Why was this product recalled? ▼
Lack of 510(k) clearance.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on January 29, 2025. Severity: Moderate. Recall number: Z-0969-2025.
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