Adept Medical Ltd recalls Otological Ventilation Tube - Donaldson - Double - Blue Silicone

Lack of 510(k) clearance.

Otological Ventilation Tube - Donaldson - Double - Blue Silicone; Product Code: NZ3321-2;

On November 25, 2024 distributors were emailed URGENT MEDICAL ADVISORY RECALL NOTICES. We request that you please: 1. Complete the enclosed Recall Acknowledgement Form (even if you have no stock, please confirm via the No Stock tick box). 2. If you have stock, quarantine all stock of the above products. 3. Return the quarantined product to Adept Medical Ltd for credit processing as below. You should also check any stock held elsewhere in your organization. " If returning stock, please return stock with the completed Recall Acknowledgement Form to accompany the returned boxes. " Use our UPS account details as UPS :9F496F , postcode 2022 to process return freight " Send Completed Recall Acknowledgement Form to Yi Huang, Quality and Regulatory Manager, yhuang@adept.co.nz and Viv So, Technical File Manager vso@adept.co.nz We sincerely apologize for the inconvenience caused and assure you that the crediting of your returns will be treated as a matter of utmost urgency.

• FDA enforcement recordOfficial FDA database entry for Z-0970-2025
• FDA 510(k) clearance · K061058The device's official FDA premarket clearance record
• FDA device classification · ETDOfficial FDA classification for this device type
• CFR regulation · 21 CFR 874.3880The federal regulation governing this device
• FDA recall announcementSearch FDA.gov for the official press announcement
• Find Adept Medical LtdSearch for the manufacturer's official notice
• News coverageRecent reporting on this recall and manufacturer
• openFDA data recordThe raw JSON record this page is built from

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.